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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000712404
Ethics application status
Approved
Date submitted
1/05/2025
Date registered
4/07/2025
Date last updated
4/07/2025
Date data sharing statement initially provided
4/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Testing a Pacemaker Upgrade: A Study of Left Bundle Branch Area Pacing (a Newer Heart Pacing Method) for Heart Failure Patients Whose Current Pacemaker Isn't Helping Enough
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Scientific title
A Feasibility Study of Left Bundle Branch Area Pacing Upgrade for Cardiac Resynchronisation Therapy Patients who are Non-Responsive: Assessing Recruitment Feasibility, Procedural Feasibility, and Follow-up Adherence.
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Secondary ID [1]
314309
0
None
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Universal Trial Number (UTN)
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Trial acronym
UPGRADE-CRT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Shortness of Breath
337320
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Condition category
Condition code
Cardiovascular
333706
333706
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Left Bundle Branch Area Pacing (LBBAP) intervention for this study involves:
What it involves for participants: Participants will undergo a further surgical procedure to upgrade their existing Cardiac Resynchronisation Therapy (CRT) pacemaker system. This involves a specialist heart doctor (electrophysiologist) implanting a new, thin pacing wire (lead, specifically a Medtronic 3830 model) into a precise location in the heart muscle (the interventricular septum, aiming for the left bundle branch area). This is done via a vein, typically under the collarbone, using X-ray guidance. The existing wire in the heart's vein (coronary sinus lead) will then be disconnected from the pacemaker device, and the new LBBAP lead will be connected. This is not an external modification; it is an invasive surgical upgrade to their implanted device.
Frequency/duration of the intervention: The LBBAP upgrade procedure is a one-time surgical event. While the protocol doesn't specify an exact duration for the surgery itself (it's listed as a procedural success metric to be recorded), such procedures typically last one hour. Once the new lead is implanted and functioning, the LBBAP is continuous. Participants will then be followed up for observation and data collection at scheduled visits (2 months, 6 months, and 12 months post-procedure).
Who will be administering the intervention: The LBBAP upgrade procedure will be performed by Staff Specialist Electrophysiologists (cardiologists specializing in heart rhythm disorders) at the participating study hospitals.
Standardized or individualized protocol: All participants will undergo the same LBBAP upgrade procedure with the goal of achieving effective pacing from the left bundle branch area. However, the precise final position of the new pacing lead within the heart's septum, and the electrical settings used to confirm optimal LBBAP capture (like sensing, pacing thresholds, and QRS morphology/duration), will be individualized for each participant during the procedure to ensure the best possible physiological pacing based on their specific anatomy and cardiac electrical activity.
Monitoring adherence to the intervention: Adherence to the LBBAP intervention (meaning the LBBAP system is implanted and functioning as intended to provide pacing) is monitored through regular device interrogations at follow-up visits. These interrogations allow the study team to check the LBBAP lead's parameters (e.g., stability, electrical measurements) and confirm ongoing effective pacing, thus ensuring the intervention is being delivered as planned.
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Intervention code [1]
330955
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Treatment: Devices
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Comparator / control treatment
1. Clarification of the "Control" Statement:
This study uses a pre-post interventional design where each participant acts as their own control. Key clinical outcome measures (such as left ventricular ejection fraction, left ventricular end systolic volume, quality of life scores via KCCQ-12, NYHA functional class, and BNP levels) along with data on hospitalisations for heart failure, will be collected from participants before they undergo the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure. These pre-intervention baseline data will then be compared to the same measures collected at scheduled follow-up points (at 2, 6, and 12 months) after the LBBAP upgrade has been implemented. The 'control' period effectively represents each participant's status and outcomes while on their existing, optimized conventional Cardiac Resynchronisation Therapy (CRT) prior to receiving the LBBAP intervention.
2. Time Period for 'Control' Data Collection:
The 'control' data, representing the participant's status prior to the LBBAP intervention, is collected over several defined periods:
Participants must have had their existing conventional Cardiac Resynchronisation Therapy (CRT) device for at least 6 months before enrollment, and their non-response to this therapy is confirmed based on assessments made after this minimum 6-month period on CRT.
Specific baseline measures for the LBBAP upgrade study (including echocardiogram, KCCQ-12, NYHA class, BNP levels, and device interrogation data from their existing CRT) are collected during the pre-procedure/enrollment phase, typically within 30 days before the LBBAP upgrade. An existing echocardiogram may be used for baseline if performed within the 3 months prior to the LBBAP procedure.
Prior to collecting these LBBAP study baseline measures, the participant's existing CRT device settings are reviewed and optimized if necessary. This ensures the pre-intervention 'control' data reflects their best achievable state on conventional CRT.
For certain historical data, such as the number of hospitalisations for heart failure, information will be collected pertaining to the period since their original CRT implantation and prior to the LBBAP upgrade. This timeframe will vary per participant but will be at least 6 months.
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Control group
Active
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Outcomes
Primary outcome [1]
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Recruitment Feasibility
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Assessment method [1]
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This is a composite outcome: The feasibility outcomes related to participant recruitment (including screening numbers, eligibility rates, and enrolment rates) and participant withdrawal (including rates and reasons for withdrawal, which informs follow-up adherence) will be assessed through an audit and analysis of contemporaneously maintained study-specific logs. These logs will include: Screening Logs: Documenting all potential participants assessed for eligibility, eligibility status, and reasons for non-inclusion if applicable. Enrollment Logs: (Often a master participant list) detailing all participants enrolled, with dates of enrollment. Participant Withdrawal Logs/Forms: Recording any participant who withdraws from the study, the date of withdrawal, and the primary reason for withdrawal. Data captured in Case Report Forms (CRFs), which may be electronic (e.g., within REDCap as mentioned in the protocol), will also serve as a source for enrollment dates, visit completion (for follow-up adherence), and details pertaining to participant status or withdrawal. These logs and relevant CRF data will be maintained as part of the Trial Master File (TMF) / Investigator Site File (ISF).
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Timepoint [1]
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Baseline Assessments: Conducted "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)." This period includes eligibility screening, informed consent, and collection of all baseline clinical data, questionnaires, and biological samples as specified in the protocol. Immediate Post-Intervention Assessments: Conducted "Within 24 hours following completion of the LBBAP upgrade procedure.". Pre-Discharge Assessments: Conducted "Prior to hospital discharge, typically between 0 and 7 days after the LBBAP upgrade procedure.". 2-Month Follow-up: Conducted "At 2 months (with a window of ± 14 days) post-LBBAP upgrade procedure commencement.". 6-Month Follow-up: Conducted "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement.". 12-Month Follow-up / End of Study Treatment: Conducted "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement." This visit also serves as the End of Treatment (EOT) assessment
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Primary outcome [2]
341300
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Procedural Feasibility
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Assessment method [2]
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This will be a composite outcome. Data for assessing procedural feasibility will be collected contemporaneously during and immediately after the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure. The specific sources include: Intra-procedural records and Case Report Forms (CRFs): Key metrics such as procedure completion status, total procedure duration, fluoroscopy time, achievement of successful Left Bundle Branch (LBB) capture (confirmed by target QRS duration <130ms, paced Left Ventricular Activation Time (pLVAT) <80ms, and characteristic ECG changes), and any intra-procedural adverse events will be recorded by the performing Staff Specialist Electrophysiologist or designated study personnel on study-specific CRFs. Cardiac Device Programmer System Reports: Electrical parameters essential for confirming lead stability and successful LBBAP, such as pacing thresholds, sensing values (e.g., R-wave amplitude), and impedance measurements, will be obtained directly from the cardiac device programmer system used during the implant procedure. Printouts or digital exports from this system will be collected. Patient's Hospital Medical Records: The official hospital medical record, including the operative/procedure note dictated by the electrophysiologist, will serve as a source document for procedure details, including confirmation of the LBBAP attempt and any documented complications. Post-procedural Imaging and ECGs: Results from post-procedural assessments such as fluoroscopy images, chest X-ray reports, and 12-lead ECGs, used to confirm final lead position and assess acute outcomes, will be collected from the respective hospital systems or patient medical records. This information will subsequently be entered into the study database (e.g., REDCap, as mentioned in the protocol) for analysis
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Timepoint [2]
341300
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The outcomes for procedural feasibility are assessed and data are collected at timepoints directly related to the LBBAP upgrade procedure (intervention commencement) for each participant within the 24 hour peri-procedural window. Any intra-procedural adverse events are also recorded at this time. Intra-procedural Feasibility Metrics: Data such as procedure completion status, total procedure duration, fluoroscopy time, success in achieving Left Bundle Branch (LBB) capture (e.g., target QRS duration, paced Left Ventricular Activation Time (pLVAT), ECG characteristics), and initial lead stability parameters (pacing thresholds, R-wave amplitude, impedance) will be recorded during the actual LBBAP upgrade procedure for each participant.
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Primary outcome [3]
341301
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Follow-Up Adherence
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Assessment method [3]
341301
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Data to assess follow-up adherence will be collected by tracking participant attendance at scheduled study visits and the completion of all protocol-specified assessments at those visits. The specific sources for these data include: Study-Specific Visit Tracking Logs and Checklists: These will be maintained by study personnel to record the date of each scheduled follow-up visit (at 2 months, 6 months, and 12 months post-LBBAP upgrade procedure) and to confirm whether the participant attended and completed all required assessments and data collection activities for that visit, as outlined in the study's Schedule of Appointments. Case Report Forms (CRFs): Both paper and/or electronic CRFs (e.g., within REDCap as mentioned in the protocol) will be utilized. These forms will have dedicated sections for each follow-up visit to document attendance, the date of the visit, and the completion status of all required study procedures, questionnaires, and data points. Electronic Study Database (e.g., REDCap): Information from the visit tracking logs and CRFs, including visit attendance and data completeness, will be entered into the central electronic study database. This database will allow for systematic tracking and calculation of adherence rates (e.g., proportion of participants completing scheduled visits and assessments). Participant Withdrawal Logs/Forms: If a participant withdraws consent or is lost to follow-up, this information, including the date and reason (if available), will be documented. This is crucial for accurately calculating follow-up adherence. These sources will enable the study team to systematically monitor and quantify participants' compliance with the scheduled follow-up visits and data collection protocols.
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Timepoint [3]
341301
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Assessment of follow-up adherence (defined as participants' compliance with scheduled visits and data collection protocols) is determined at the following key timepoints: 2-Month Follow-up Visit: Adherence is assessed based on attendance and completion of required study procedures at the visit scheduled "At 2 months (with a window of ± 14 days) post-LBBAP upgrade procedure commencement". 6-Month Follow-up Visit: Adherence is assessed based on attendance and completion of required study procedures at the visit scheduled "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Follow-up / End of Study Treatment Visit: Adherence is assessed based on attendance and completion of required study procedures at the visit scheduled "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". The successful completion of these scheduled visits and the data collection protocols therein form the basis for evaluating the 'follow-up adherence' feasibility outcome
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Secondary outcome [1]
447057
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Left Ventricular Ejection Fraction
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Assessment method [1]
447057
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Transthoracic Echo
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Timepoint [1]
447057
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For the secondary outcome LVEF (Left Ventricular Ejection Fraction), the timepoints for assessment are anchored relative to the participant and the LBBAP intervention as follows: Baseline LVEF: Assessed via echocardiogram "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)." The protocol also notes that an echocardiogram performed within the 3 months prior to this pre-procedure window may be used as the baseline measurement. 6-Month Post-Intervention LVEF: Assessed via echocardiogram "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Post-Intervention LVEF: Assessed via echocardiogram "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". These timepoints will allow for the assessment of change in LVEF from baseline to the 6 and 12-month follow-up points after the LBBAP intervention
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Secondary outcome [2]
447058
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Left Ventricular End-Systolic Volume
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Assessment method [2]
447058
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Transthoracic Echo
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Timepoint [2]
447058
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For the secondary outcome LVESV (Left Ventricular End Systolic Volume), the timepoints for assessment are anchored relative to the participant and the LBBAP intervention as follows: Baseline LVESV: Assessed via echocardiogram "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)." The protocol also indicates that an echocardiogram performed within the 3 months prior to this pre-procedure window may be used as the baseline measurement. 6-Month Post-Intervention LVESV: Assessed via echocardiogram "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Post-Intervention LVESV: Assessed via echocardiogram "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". These timepoints will allow for the assessment of change in LVESV from baseline to the 6 and 12-month follow-up points after the LBBAP intervention
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Secondary outcome [3]
447059
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Quality of Life
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Assessment method [3]
447059
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Kansas City Heart Failure Questionnaire (KCCQ-12)
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Timepoint [3]
447059
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For the secondary outcome of quality of life, assessed using the KCCQ-12 (Kansas City Cardiomyopathy Questionnaire), the timepoints for assessment are anchored relative to the participant and the LBBAP intervention as follows: Baseline KCCQ-12: The KCCQ-12 questionnaire is administered "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)". 6-Month Post-Intervention KCCQ-12: The KCCQ-12 questionnaire is administered "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Post-Intervention KCCQ-12: The KCCQ-12 questionnaire is administered "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". These timepoints will allow for the assessment of change in quality of life from baseline to the 6 and 12-month follow-up points after the LBBAP intervention
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Secondary outcome [4]
447060
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New York Heart Association Class (NYHA Class)
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Assessment method [4]
447060
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Clinical assessment by trial clinician
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Timepoint [4]
447060
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For the secondary outcome of New York Heart Association (NYHA) class, the timepoints for assessment are anchored relative to the participant and the LBBAP intervention as follows: Baseline NYHA Class: Assessed "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)". 6-Month Post-Intervention NYHA Class: Assessed "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Post-Intervention NYHA Class: Assessed "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". These timepoints will allow for the assessment of change in NYHA class from baseline to the 6 and 12-month follow-up points after the LBBAP intervention
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Secondary outcome [5]
447061
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Brain natriuretic peptide (BNP)
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Assessment method [5]
447061
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Blood pathology
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Timepoint [5]
447061
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For the secondary outcome specifically of BNP (Brain Natriuretic Peptide) levels, the timepoints for assessment are anchored relative to the participant and the LBBAP intervention as follows: Baseline BNP: Collected "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)". 6-Month Post-Intervention BNP: Collected "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Post-Intervention BNP: Collected "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". These timepoints will allow for the assessment of change in BNP levels from baseline to the 6 and 12-month follow-up points after the LBBAP intervention
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Secondary outcome [6]
447062
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Atrial Fibrillation Burden
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Assessment method [6]
447062
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Interrogation of cardiac device data
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Timepoint [6]
447062
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For the secondary outcome of atrial fibrillation (AF) burden, which is assessed by interrogation of cardiac device data, the timepoints for assessment are anchored relative to the participant and the LBBAP intervention as follows: Baseline AF Burden: Assessed via cardiac device interrogation "Within 30 days prior to the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement)." This interrogation will review the AF burden recorded by the participant's existing CRT device before the upgrade. 6-Month Post-Intervention AF Burden: Assessed via cardiac device interrogation "At 6 months (with a window of ± 15 days) post-LBBAP upgrade procedure commencement". 12-Month Post-Intervention AF Burden: Assessed via cardiac device interrogation "At 12 months (with a window of ± 30 days) post-LBBAP upgrade procedure commencement". While device interrogations (which collect AF burden data) also occur at pre-discharge and at the 2-month follow-up visit, the formal secondary outcome analysis for change in AF burden, as stated in the protocol, focuses on the baseline, 6-month, and 12-month timepoints
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Secondary outcome [7]
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Hospitalisation for Heart Failure
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Assessment method [7]
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This information will be gathered directly from the patient at any one of their follow up visits and cross-checked with their medical record. There is also the opportunity for treating clinicians not involved in the trial to notify trial staff regarding this. The cardiac devices cannot alert clinicians of admission to hospital unfortunately.
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Timepoint [7]
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Data on hospitalisations for heart failure will be collected for two main periods: Pre-Intervention Period: Information is gathered for hospitalisations occurring from the participant's original Cardiac Resynchronisation Therapy (CRT) implantation date up to the day before the Left Bundle Branch Area Pacing (LBBAP) upgrade procedure (intervention commencement). Post-Intervention Period: Information is gathered for hospitalisations occurring from the day of the LBBAP upgrade procedure (intervention commencement) throughout the 12-month study follow-up. This information is actively collected at scheduled follow-up visits, which occur at 2 months (±14 days), 6 months (±15 days), and 12 months (±30 days) post-LBBAP upgrade procedure commencement
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Secondary outcome [8]
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Procedural Complications
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Assessment method [8]
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Collection of specific procedural adverse events (including but not limited to bleeding requiring intervention, pneumothorax requiring intervention, cardiac tamponade/pericardial effusion requiring intervention, coronary artery dissection, stroke or thromboembolic event related to procedure, acute septal perforation requiring intervention) occurring during or as a direct consequence of the LBBAP upgrade procedure. Assessed by direct clinical observation, review of operative notes, post-procedure imaging, physical examination, laboratory tests if indicated, and participant reporting. All recorded in patient medical records and study adverse event logs
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Timepoint [8]
447800
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During the LBBAP procedure, within 24 hours post-procedure, and up to pre-discharge (0-7 days post-LBBAP upgrade procedure commencement)
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Secondary outcome [9]
447801
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Worsening Left Ventricular Ejection Fraction (LVEF) >10% post-intervention
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Assessment method [9]
447801
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Comparison of LVEF measured by echocardiography from baseline to post-intervention measurements
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Timepoint [9]
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LVEF assessed at Baseline (within 30 days prior to LBBAP upgrade procedure commencement or using an echo from the prior 3 months), then at 6 months (±15 days) and 12 months (±30 days) post-LBBAP upgrade procedure commencement
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Secondary outcome [10]
447802
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Worsening of New York Heart Association (NYHA) Class post-intervention
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Assessment method [10]
447802
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Clinical assessment of NYHA functional class by study investigator/physician, compared to baseline.
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Timepoint [10]
447802
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NYHA Class assessed at Baseline (within 30 days prior to LBBAP upgrade procedure commencement), then at 6 months (±15 days) and 12 months (±30 days) post-LBBAP upgrade procedure commencement
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Secondary outcome [11]
447803
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Requirement for LBBAP lead repositioning
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Assessment method [11]
447803
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Clinical decision by the treating electrophysiologist based on findings from cardiac device interrogation (e.g., unacceptable sensing, high pacing thresholds, loss of capture), 12-lead ECG (loss of LBB capture criteria), participant symptoms, and/or imaging. Documented in medical records and study adverse event/device tracking logs
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Timepoint [11]
447803
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Assessed at the time of LBBAP procedure, immediate post-procedure period (<24 hours, pre-discharge 0-7 days), and at all scheduled follow-up device interrogations (2 months ±14 days, 6 months ±15 days, and 12 months ±30 days post-LBBAP upgrade procedure commencement), or if clinically indicated between visits
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Secondary outcome [12]
448293
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Requirement for LBBAP lead removal
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Assessment method [12]
448293
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Clinical decision by the treating electrophysiologist based on findings from cardiac device interrogation (e.g., unacceptable sensing, high pacing thresholds, loss of capture), 12-lead ECG (loss of LBB capture criteria), participant symptoms, and/or imaging. Documented in medical records and study adverse event/device tracking logs
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Timepoint [12]
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Assessed at the time of LBBAP procedure, immediate post-procedure period (<24 hours, pre-discharge 0-7 days), and at all scheduled follow-up device interrogations (2 months ±14 days, 6 months ±15 days, and 12 months ±30 days post-LBBAP upgrade procedure commencement), or if clinically indicated between visits
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Eligibility
Key inclusion criteria
1. Patients with Heart Failure with reduced Ejection Fraction (HFrEF) with existing Cardiac Resynchronisation Therapy (CRT) who are at least 6 months post-implant and are showing signs of CRT non-response.
2. CRT (Defibrillator or Pacemaker) of greater than or equal to 6 months duration
3. New York Heart Association (NYHA) class II-IV symptoms
4. Native QRS width of 150-180ms and Left Bundle Branch Block (LBBB)
5. Greater than or equal to 90% Biventricular (BiV) pacing
6. Ejection Fraction (EF) less than or equal to 35% and improvement from baseline EF less than or equal to 10% post CRT implant after at least 6 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Cognitive impairment: Defined as diagnosed cognitive disorders such as dementia or other neurodegenerative diseases, or a history of stroke or traumatic brain injury resulting in low scores on cognitive tests like the Mini-Mental State Examination (MMSE) (scores within the range of 19 to 23 inclusive, out of 30) or Montreal Cognitive Assessment (MoCA) (scores within the range of 18 to 25 inclusive, out of 30). Also includes significant functional impairments in daily living due to cognitive deficits from severe psychiatric disorders.
Chronic infection: (This is a major contraindication to cardiac device insertion).
Metastatic cancer: (This is likely to confound the validity of the primary outcome and is likely to negatively affect wound healing and the safety of the upgrade procedure).
Patients with a prognosis of less than 12 months will be excluded given the 12-month enrolment period of the study.
Patients with New York Heart Association (NYHA) Class I symptoms will be excluded as they are unlikely to have Cardiac Resynchronisation Therapy (CRT) non-response by definition and cannot see improvement with respect to the primary outcome.
Severe Pulmonary hypertension secondary to a non-cardiac condition.
Uncontrolled Obstructive Sleep Apnoea secondary to a non-cardiac condition.
Severe renal impairment (e.g., estimated Glomerular Filtration Rate (eGFR) less than 30 mL/min/1.73 m²).
Advanced Liver Disease (Child-Pugh Score greater than or equal to B7 or Model for End-Stage Liver Disease (MELD) Score greater than or equal to 15).
Untreated iron deficiency defined as Serum Ferritin less than 100 ng/mL, or Serum Ferritin between 100-299 ng/mL with Transferrin Saturation (TSAT) less than 20%.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/08/2025
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Actual
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Date of last participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last data collection
Anticipated
6/07/2027
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
318831
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Hospital
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Name [1]
318831
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In-Kind Support from Princess Alexandra Hospital
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Address [1]
318831
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Country [1]
318831
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Australia
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Primary sponsor type
Hospital
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Name
Princess Alexandra Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321322
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Address [1]
321322
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Country [1]
321322
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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29/01/2024
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Approval date [1]
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25/03/2025
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Ethics approval number [1]
317447
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Summary
Brief summary
This study looks at patients with heart failure who have a special type of pacemaker called CRT, but sadly aren't feeling much better. Researchers want to test if upgrading this pacemaker using a newer technique, called Left Bundle Branch Area Pacing (LBBAP), is a practical option for these patients. The main goal isn't to prove the upgrade works yet, but simply to see if the procedure itself, recruiting patients, and follow-up appointments can be done smoothly at the Gold Coast University and Princess Alexandra Hospitals. About 25 patients will participate in this initial 'feasibility' study. The results will help doctors decide if it's worth doing a larger study in the future to properly check if this pacemaker upgrade helps improve patients' health and quality of life.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Matthew Rowe
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Address
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 07 31762111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Patrick Brown
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Address
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 07 31762111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Patrick Brown
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Address
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+61 07 31762111
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Fax
141064
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Email
141064
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Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
2025.03.25 HREC Approval letter_105789.pdf
Informed consent form
PICF (UPGRADE-CRT)_MASTER COPY v4 25.03.2025_clean.docx
Study protocol
UPGRADE CRT PROTOCOL FINAL v4 25 FEB 2025_clean (comments removed).docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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