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Role of Left Bundle Branch (LBB) pacing in heart failure - An Observational Study

Comparing efficacy of Left Bundle Branch Pacing (LBBP) to traditional BiVentricular Pacing (BVP) Cardiac Resynchronization Therapy (CRT) in heart failure - Select Site : Cohort study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000088640
Enrollment
150
Registered
2023-01-25
Start date
2023-02-20
Completion date
2023-03-31
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 electrophysiolo

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

Sponsors

DR. RAJEEV PATHAK
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026