Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
LBAP-TAVI
Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
1 other identifier
interventional
266
1 country
7
Brief Summary
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients. Conventional right ventricular pacing in these cases often leads to interventricular dyssynchrony, which can impair left ventricular ejection fraction and increase the risk of hospitalization, heart failure, and mortality. Cardiac resynchronization therapy via biventricular pacing is sometimes proposed as a secondary intervention but involves additional surgery. A newer pacing technique-selective left bundle branch area pacing-has been developed to provide physiological ventricular activation by stimulating conduction pathways distal to the lesion, thereby avoiding dyssynchrony. Retrospective studies suggest clinical benefits, but no prospective randomized trial has yet evaluated its efficacy compared to standard pacing. The objective of this study is to conduct the first randomized clinical trial comparing left bundle branch area pacing versus conventional right ventricular pacing in patients requiring pacemaker implantation due to atrioventricular block after TAVI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedFirst Posted
Study publicly available on registry
November 19, 2025
CompletedStudy Start
First participant enrolled
November 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
April 15, 2026
April 1, 2026
3.9 years
September 8, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
number of cardiovascular deaths
24 months
number of hospitalizations for heart failure
24 months
number of surgical reinterventions
24 months
Secondary Outcomes (10)
success rate of the LBAP technique
3, 12, and 24 months post-implantation
comparison of immediate and long-term complications of the LBAP stimulation
3, 12, and 24 months post-implantation
ECG measurements
3, 12, and 24 months post-implantation
left ventricular function (LVEF)
3, 12, and 24 months post-implantation
left ventricular diameter
3, 12, and 24 months post-implantation
- +5 more secondary outcomes
Study Arms (2)
LBAP : Left Bundle Area Pacing
EXPERIMENTALPacemaker implantation using left bundle branch area stimulation
RVP : Right Ventricular Pacing
PLACEBO COMPARATORRight ventricular pacemaker implantation
Interventions
Right ventricular pacemaker implantation
Pacemaker implantation using left bundle branch area stimulation
Eligibility Criteria
You may qualify if:
- Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- Preserved left ventricular ejection fraction (LVEF ≥ 50%)
- Indications for pacemaker implantation according to guidelines, including :
- Third-degree atrioventricular (AV) block
- Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
- Alternating left and right bundle branch block
- HV interval ≥ 70 ms during electrophysiological study
- Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI
- Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation
- Signed informed consent
- Patient affiliated with the national health insurance system
You may not qualify if:
- Left ventricular ejection fraction (LVEF) \< 50% before TAVI
- Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
- Previously implanted pacemaker
- Patients under legal guardianship, curatorship, or judicial protection
- Participation in another interventional therapeutic clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Brest University Hospital
Brest, Finistère, 29200, France
Rennes University Hospital
Rennes, Ille-et-Vilaine, 35033, France
Tours University Hospital
Tours, Indre-et-Loire, 37044, France
Nantes University Hospital
Nantes, Loire-Atlantique, 44093, France
Clermont Ferrand University Hospital
Clermont-Ferrand, Puy-de-Dôme, 63003, France
Rouen University Hospital
Rouen, Seine-Maritime, 76031, France
Poitiers University Hospital
Poitiers, Vienne, 86021, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2025
First Posted
November 19, 2025
Study Start
November 25, 2025
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04