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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12624000304538
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
22/03/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
COMPARison of Lumenless versus Stylet-driven Lead Systems in Left Bundle Branch Pacing - COMPARE LBBP
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Scientific title
COMPARison of procedural outcomes of Lumenless versus Stylet-driven Lead Systems in Left Bundle Branch Pacing - COMPARE LBBP
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Secondary ID [1]
311567
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bradycardia
332937
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Heart failure
332938
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Pacemaker induced cardiomyopathy
332965
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Condition category
Condition code
Cardiovascular
329654
329654
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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
Left bundle branch pacing (LBBP) is a rapidly emerging pacing modality. Traditionally, lumenless fixed helix lead is used for LBBP delivered with a fixed curve or preshaped deflectable delivery catheter. However, it can also be done with stylet driven lead when used with appropriate delivery catheter. In this clinical trial one arm will receive lumen less lead and another will receive stylet driven lead for LBBP. No investigational therapy is involved as both methods are tested and currently in use.
Intervention arm will receive stylet driven lead system. LBBP will be performed with stylet driven lead delivered to target location through a delivery catheter. A pre-shaped delivery catheter (such as CPS Locator 3D sheth) will be used which is standard of care. Left bundle capture will be confirmed by paced RBBB morphology plus one of the following.
1. V6-R wave peak time <75 ms in patients with narrow QRS and <80 ms in patients with bundle branch block, 2. V6-V1 inter peak interval of >44 ms, 3. transition from nonselective to selective left bundle branch or left ventricular septal capture. 'Template beat' be used to guide the procedure if induced during lead implantation.
Procedure will be performed once and confirmation of left bundle branch capture will be considered acute success. Usual procedural duration is ~1-2 hours. Procedure will be performed by experienced cardiac electrophysiologist specialised in left bundle branch pacing.
Another cardiac electrophysiologist will be independently responsible for validating the left bundle branch capture and independent team of cardiac physiologists will be responsible for collecting data regarding procedure start, end and electrocardiographic parameters.
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Intervention code [1]
328022
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Treatment: Devices
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Comparator / control treatment
Lumenless lead for LBBP
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Control group
Active
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Outcomes
Primary outcome [1]
337442
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Acute implant success rate
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Assessment method [1]
337442
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Successful capture of left bundle branch as indicated by paced RBBB morphology plus one of the following criteria. 1) V6 RWPT of <75 ms in patients with narrow QRS or <80 ms in patients with Brundle branch block, 2) V6-V1 inter-peak interval >44 ms 3) Transition from nonselective to selective left bundle branch or left ventricular septal capture during procedure. Occurrence of the 'template beat' will be observed during the procedure and used as a marker of the left bundle branch capture. Appearance of paced right bundle branch pacing morphology without above mentioned criteria will considered as left bundle branch area pacing. Inability to implant the lead in left bundle branch/left ventricular septum and implantation into right ventricular septum will be considered as traditional right ventricular septal pacing.
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Timepoint [1]
337442
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At implant
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Secondary outcome [1]
431869
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Terminal r/R' wave in lead V1 - Right Bundle Branch Block morphology in lead V1
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Assessment method [1]
431869
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On surface electrocardiogram in cardiac electrophysiology laboratory
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Timepoint [1]
431869
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At implant
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Secondary outcome [2]
431870
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Transition from non-selective to selective LBBP or non-selective LBBP to left ventricular myocardial capture during decreasing pacing output
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Assessment method [2]
431870
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On surface ECG in cardiac electrophysiology laboratory
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Timepoint [2]
431870
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At implant
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Secondary outcome [3]
431871
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Abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) by 10 ms or more during implantation
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Assessment method [3]
431871
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On surface ECG in cardiac electrophysiology laboratory
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Timepoint [3]
431871
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At implant
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Secondary outcome [4]
431872
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V6RWPT < 75ms or < 80ms in patients with preexisting bundle branch block
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Assessment method [4]
431872
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On surface ECG in cardiac electrophysiology laboratory
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Timepoint [4]
431872
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At implant
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Secondary outcome [5]
431873
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An interpeak interval (V1RWPT - V6RWPT) > 33ms
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Assessment method [5]
431873
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On surface ECG in cardiac electrophysiology laboratory
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Timepoint [5]
431873
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At implant
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Secondary outcome [6]
431874
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Implant related complications
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Assessment method [6]
431874
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Number of patients with major and minor complications related to the procedure (death, inter ventricular septum perforation, cardiac perforation leading to pericardial effusion and/or tamponade, reactive pericardial effusion, injury to conduction system causing permanent right bundle branch block). Septal perforation will be defined as sudden drop in unipolar impedance to <400 ohms or loss of capture during implant. Transient right bundle branch block will be discounted. Right bundle branch block persisting during follow up will be taken into account. Right bundle branch block will be observed from surface ECG. Cardiac perforation leading to tamponade and/or death are acute complications which will be diagnosed by echocardiography or fluoroscopy or CT scan pre-discharge. Pericardial effusion will be diagnosed from echocardiography.
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Timepoint [6]
431874
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Immediate post procedure period
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Secondary outcome [7]
441190
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Persistence of LBBP on follow up
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Assessment method [7]
441190
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Persistence of terminal r/R in lead V1 and stable V6RWPT as defined by absence of prolongation of V6RWPT by >10 ms compared to V6RWPT at implant as measured from surface ECG
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Timepoint [7]
441190
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1 month, 3 month and 6 months post-implant
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Secondary outcome [8]
441191
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Lead implant time
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Assessment method [8]
441191
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Time duration from lead insertion to the acceptance of the final lead position which could be left bundle branch, left ventricular septum or right ventricular septum if left bundle branch area pacing failed. The time will be measured by independent cardiac technician who will be present on site during the procedure and will measure the duration of procedure.
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Timepoint [8]
441191
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1 month, 3 month and 6 months post-implant
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Secondary outcome [9]
441192
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Lead implant time
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Assessment method [9]
441192
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Time duration from lead insertion to the acceptance of the final lead position which could be left bundle branch, left ventricular septum or right ventricular septum if left bundle branch area pacing failed. The time will be measured by independent cardiac technician who will be present on site during the procedure and will measure the duration of procedure.
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Timepoint [9]
441192
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At the time of implant
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Secondary outcome [10]
441193
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Lead implant attempts
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Assessment method [10]
441193
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Total attempt to implant the lead in the left bundle branch/left ventricular septal location. When the lead is unscrewed after initial implantation for the purpose of implanting the lead at the new location, it will be considered a new attempt. The implant attempt is assessed by implanting physician during the procedure.
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Timepoint [10]
441193
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At the time of implant
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Secondary outcome [11]
441194
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Lead implant attempts
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Assessment method [11]
441194
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Total attempt to implant the lead in the left bundle branch/left ventricular septal location. When the lead is unscrewed after initial implantation for the purpose of implanting the lead at the new location, it will be considered a new attempt. The implant attempt is assessed by implanting physician during the procedure.
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Timepoint [11]
441194
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At the time of the implant.
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Secondary outcome [12]
441195
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Fluoroscopy dose
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Assessment method [12]
441195
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Dose of fluoroscopy received by the patient during the left bundle branch pacing lead implantation. This is obtained during the procedure by implanting cardiologist who will indicate the end of 'lead implant procedure' once the final lead location is achieved and fluoroscopy dose till then will be documented.
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Timepoint [12]
441195
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At the time of the implant.
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Secondary outcome [13]
441196
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Fluoroscopy dose
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Assessment method [13]
441196
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Dose of fluoroscopy received by the patient during the left bundle branch pacing lead implantation. This is obtained during the procedure by implanting cardiologist who will indicate the end of 'lead implant procedure' once the final lead location is achieved and fluoroscopy dose till then will be documented.
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Timepoint [13]
441196
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At the time of implant.
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Secondary outcome [14]
441197
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Fluoroscopy time
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Assessment method [14]
441197
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Fluoroscopy time during left bundle branch pacing lead implant. This is obtained during the procedure by implanting cardiologist who will indicate the end of 'lead implant procedure' once the final lead location is achieved and fluoroscopy time till then will be documented.
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Timepoint [14]
441197
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At the time of implant.
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Secondary outcome [15]
441198
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Fluoroscopy time
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Assessment method [15]
441198
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Fluoroscopy time during left bundle branch pacing lead implant. This is obtained during the procedure by implanting cardiologist who will indicate the end of 'lead implant procedure' once the final lead location is achieved and fluoroscopy time till then will be documented.
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Timepoint [15]
441198
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At the time of the implant.
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Secondary outcome [16]
441199
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Lead damage during implantation requiring a new lead for implant.
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Assessment method [16]
441199
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Lead helix damage or tissue entrapment requiring use of new lead. This is obtained during the procedure by implanting cardiologist who will indicate the damage to lead helix during implantation, if any.
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Timepoint [16]
441199
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At the time of the implant.
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Secondary outcome [17]
441200
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Lead damage during implantation requiring a new lead for implant.
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Assessment method [17]
441200
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Lead helix damage or tissue entrapment requiring use of new lead. This is obtained during the procedure by implanting cardiologist who will indicate the damage to lead helix during implantation, if any.
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Timepoint [17]
441200
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At the time of the implant
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Secondary outcome [18]
441201
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Lead dislodgement requiring repeat procedure.
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Assessment method [18]
441201
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Acute lead dislodgement will be defined as lead dislodgement before patient discharge requiring new procedure. Late dislodgement will be defined as lead dislodgement occurring after discharge from hospital which requires a new procedure. Lead dislodgement or loss of capture will be determined by interrogating the device pre-discharge or form review of device parameters on follow up. Lead dislodgement will be confirmed by imaging such as X-ray or fluoroscopy.
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Timepoint [18]
441201
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At the time of the implant
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Secondary outcome [19]
441202
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Lead dislodgement requiring repeat procedure.
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Assessment method [19]
441202
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Acute lead dislodgement will be defined as lead dislodgement before patient discharge requiring new procedure. Late dislodgement will be defined as lead dislodgement occurring after discharge from hospital which requires a new procedure. Lead dislodgement or loss of capture will be determined by interrogating the device pre-discharge or form review of device parameters on follow up. Lead dislodgement will be confirmed by imaging such as X-ray or fluoroscopy.
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Timepoint [19]
441202
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Acute dislodgement measured in post-index procedure period up to the time of discharge. Late dislodgement measured in the follow up period after discharge from hospital.
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Eligibility
Key inclusion criteria
a) Age: 18 years and above
b) Recipients of left bundle branch pacing therapy
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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
a) Metallic tricuspid valve implant
b) Severe tricuspid stenosis
c) Complex congenital heart disease, dextrocardia.
d) Venous anatomy unsuitable for transvenous pacing - e.g venous stenosis, congenital malformation
e) Venous anatomy or any other pathology precluding pacing from left sided vein
e) Upgrade from a failed His bundle pacing
f) Highly dependent or with mental impairment
g) Pregnant women
h) Inability to follow up, interstate patients
i) Refuse to/unable to give consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
17/11/2023
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Date of last participant enrolment
Anticipated
15/05/2024
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Actual
31/05/2024
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Date of last data collection
Anticipated
31/05/2024
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Actual
26/08/2024
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
ACT
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Funding & Sponsors
Funding source category [1]
315867
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Self funded/Unfunded
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Name [1]
315867
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Address [1]
315867
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Country [1]
315867
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Primary sponsor type
Charities/Societies/Foundations
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Name
Canberra heart rhythm foundation
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Address
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Country
Australia
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Secondary sponsor category [1]
318006
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None
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Name [1]
318006
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Address [1]
318006
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Country [1]
318006
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314716
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ACT Health Human Research Ethics Committee
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Ethics committee address [1]
314716
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https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
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Ethics committee country [1]
314716
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Australia
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Date submitted for ethics approval [1]
314716
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19/10/2023
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Approval date [1]
314716
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16/11/2023
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Ethics approval number [1]
314716
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Summary
Brief summary
Left bundle branch pacing (LBBP) is rapidly emerging pacing therapy. Traditionally, lumenless fixed helix lead is used for LBBP which is delivered through a fixed curve or preshaped flexible curve delivery catheter. Left bundle area can also be captured with implantation of traditional stylet-driven leads delivered with the use of various delivery sheaths from different manufacturers. Currently, both techniques are in use; however, data regarding comparison of outcomes of these two different lead systems is limited. This trial aims at comparing the outcomes of these two different techniques of LBBP which are currently in use.
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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
132498
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Prof Rajeev Kumar Pathak
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Address
132498
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Canberra heart rhythm, Suite 14, 2 Garran Pl, Garran, ACT-2605
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Country
132498
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Australia
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Phone
132498
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+61477653949
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Fax
132498
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Email
132498
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[email protected]
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Contact person for public queries
Name
132499
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Rajeev Kumar Pathak
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Address
132499
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Canberra heart rhythm, Suite 14, 2 Garran Pl, Garran, ACT-2605
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Country
132499
0
Australia
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Phone
132499
0
+61477653949
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Fax
132499
0
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Email
132499
0
[email protected]
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Contact person for scientific queries
Name
132500
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Rajeev Kumar Pathak
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Address
132500
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Canberra heart rhythm, Suite 14, 2 Garran Pl, Garran, ACT-2605
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Country
132500
0
Australia
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Phone
132500
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+61477653949
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Fax
132500
0
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Email
132500
0
[email protected]
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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
Study protocol
[email protected]
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.
Download to PDF