Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000088640p
Ethics application status
Submitted, not yet approved
Date submitted
19/01/2023
Date registered
25/01/2023
Date last updated
25/01/2023
Date data sharing statement initially provided
25/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of Left Bundle Branch (LBB) pacing in heart failure - An Observational Study
Scientific title
Comparing efficacy of Left Bundle Branch Pacing (LBBP) to traditional BiVentricular Pacing (BVP) Cardiac Resynchronization Therapy (CRT) in heart failure - Select Site : Cohort study
Secondary ID [1] 308715 0
Nil known
Secondary ID [2] 308829 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 328648 0
Prolonged QRSduration (QRSd) >150 ms 328649 0
Left Bundle Branch Block (LBBB) 328656 0
Right Bundle Branch Block (RBBB) 328657 0
Condition category
Condition code
Cardiovascular 325662 325662 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
24
Target follow-up type
Months
Description of intervention(s) / exposure
Patients with heart failure and indication for pacemaker/CRT will be studied. Left Bundle Branch (LBB) pacing is done by placing lead deep into interventricular septum to capture LBB and atrial lead in RA appendage which is an emerging therapy to deliver CRT. Total procedural time is approximately 30-60min. Information about procedure will be conveyed to patients in writing before the procedure and consent will be obtained. Dr. Rajeev Pathak with 10 years of experience in cardiac electrophysiology will carry out the procedure under general anesthesia at either Canberra Hospital or National Capital Private Hospital, Garran, ACT, Australia. Procedure will be done once during the study period and patients will be observed for 24 months.

We are not testing any investigational therapy. So patients need not certainly choose to enrol into study to get LBBP treatment, they can still receive LBBP even if they choose not to enrol. We are interested in observing the patients who undergo CRT (and choose to enrol into study) with either way and the outcomes.

Following information will be collected.
Medical history to know the reason of heart failure
Exercise capacity - to categorize symptoms into NYHA class
Quality of Life - from SF36 questionnaire
All data will be collected from medical records as these are standard parameters collected for all heart failure patients
Folllow up is standard for all heart failure patients undergoing device implantation, so patients need not visit clinic specifically for us to collect data
Required data will be obtained from there medical records
Intervention code [1] 325185 0
Diagnosis / Prognosis
Comparator / control treatment

Traditional biventricular pacing involves placing pacemaker leads in Right Ventricular apex, Right Atrial Appendage and Coronary Sinus which is current gold standard. Procedure usually is offered to patients with heart failure and prolonged QRSd despite optimal medical management. Usual procedural time ~60-90min.
Control group
Active

Outcomes
Primary outcome [1] 333514 0
Left Ventricular Ejection Fraction by echocardiography
Timepoint [1] 333514 0
6 months, 12 months, 24 months post CRT
Primary outcome [2] 333515 0
QRSd by 12 lead ECG
Timepoint [2] 333515 0
6 months, 12 months, 24 months post CRT
Secondary outcome [1] 417363 0
Symptoms - New York Heart Association (NYHA) class
Timepoint [1] 417363 0
6 months, 12 months, 24 months post CRT
Secondary outcome [2] 417364 0
Quality of Life by SF36 questionnaire - Patient reported survey of patient health
Timepoint [2] 417364 0
6 months, 12 months, 24 months post CRT
Secondary outcome [3] 417367 0
LV end diastolic volume by echocardiography
Timepoint [3] 417367 0
6 months, 12 months, 24 months post CRT
Secondary outcome [4] 417395 0
LV end systolic volume by echocardiography
Timepoint [4] 417395 0
6 months, 12 months, 24 months post CRT

Eligibility
Key inclusion criteria
Severe LV systolic dysfunction despite optimal medical management and indication for Permanent Pacemaker/CRT
Prolonged QRSd >150MS
Left Bundle Branch Block (LBBB) or
Right Bundle Branch Block (RBBB) or
Inter-Ventricular Conduction Delay (IVCD)
Symptoms - NYHA Class II AND III
Where tradition Biventricular pacing or LBB pacing is possible, i.e absence of complex congenital heart disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with limited life expectancy due to comorbidity
Advanced cancer
Refuse to/unable to give consent
Complex congenital heart disease where lead placement is not possible
Pregnancy
When heart failure or prolonged QRS are assumed to be transient and expected to recover

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The statistical methodology for the study has been determined in consultation with the Data Management and Analysis Centre, The Canberra Hospital. The primary endpoints of the study are improvement in LVEF and QRSd reduction.
All analyses will be based on the intention to treat principle. The primary outcomes of LVEF improvement and QRSd reduction in study cohort will be compared to active comparator arm using independent samples t-test. Differences in LVEF and QRSd will be expressed using means and 95% confidence interval. Key secondary outcomes such as LV end systolic and end diastolic volumes will be expressed in mean and compared using t-test. Continuous secondary outcomes such as the NYHA class, SF36 scores will be compared between randomised groups over time using linear mixed effects models.
All continuous variables will be reported as mean +/- standard deviation where normally distributed. Statistical significance will be two-sided and will be established at p<0.05.
Echocardiographic, electrocardiographic and symptomatic outcomes for patients will be evaluated as described above.
The outcomes of the study groups will be compared by mixed effects modelling to determine the effect of pacing modality on the primary endpoint.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
15/05/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 23788 0
National Capital Private Hospital - Garran
Recruitment hospital [2] 23789 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 39238 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 312938 0
Self funded/Unfunded
Name [1] 312938 0
DR. RAJEEV PATHAK
Country [1] 312938 0
Australia
Primary sponsor type
Individual
Name
DR. RAJEEV PATHAK
Address
Canberra Heart Rhythm,
1st floor, 2 Garran Pl,
Garran, ACT - 2605
Country
Australia
Secondary sponsor category [1] 314626 0
None
Name [1] 314626 0
Address [1] 314626 0
Country [1] 314626 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312211 0
The Canberra Hospital Ethics Committee
Ethics committee address [1] 312211 0
Yamba drive, Garran, ACT - 2605
Ethics committee country [1] 312211 0
Australia
Date submitted for ethics approval [1] 312211 0
19/01/2023
Approval date [1] 312211 0
Ethics approval number [1] 312211 0

Summary
Brief summary
This is a prospective cohort study to observe the efficacy of LBB pacing, a newer pacing modality to the current gold standard of BiVentricular Pacing (BVP). All patients with heart failure and an indication for pacing/CRT will be selected and categorized into two cohorts.
Intervention under study cohort - patients who will undergo LBB pacing CRT
Comparator cohort - patients who will undergo biventricular pacing CRT
It is a multicentre cohort study and those undergoing CRT at two centres - the Canberra hospital and the National capital private hospital will be enrolled. CRT is cornerstone of heart failure management apart from optimal medical treatment. BVP is current gold standard of delivering CRT but LBB pacing is a new modality which recruits conduction system and physiologically depolarises LV and could be more efficacious in improving LVEF, QRS duration and symptoms.. However, literature regarding this is scarce. We aim to compare these two cohorts in terms of primary outcomes including effect on LVEF and QRSd on follow up and secondary outcome including LV end diastolic and end systolic volumes and effect on NYHA class and QoL. The outcome data will help us understanding whether LBB pacing is more efficacious and will support conduction of prospective Randomized Control Trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123862 0
Prof RAJEEV KUMAR PATHAKRajeev Kumar Pathak
Address 123862 0
Canberra Heart Rhythm
1st floor, 2 Garran Pl,
Garran, ACT 2605
Country 123862 0
Australia
Phone 123862 0
+61 477653949
Fax 123862 0
Email 123862 0
rajeev.pathak@canberraheartrhythm.com.au
Contact person for public queries
Name 123863 0
Prof Rajeev Kumar Pathak
Address 123863 0
Canberra Heart Rhythm
1st floor, 2 Garran Pl,
Garran, ACT 2605
Country 123863 0
Australia
Phone 123863 0
+61 477653949
Fax 123863 0
Email 123863 0
rajeev.pathak@canberraheartrhythm.com.au
Contact person for scientific queries
Name 123864 0
Prof Rajeev Kumar Pathak
Address 123864 0
Canberra Heart Rhythm
1st floor, 2 Garran Pl,
Garran, ACT 2605
Country 123864 0
Australia
Phone 123864 0
+61 477653949
Fax 123864 0
Email 123864 0
rajeev.pathak@canberraheartrhythm.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.