Actively Recruiting
Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
Led by Nantes University Hospital · Updated on 2026-04-15
266
Participants Needed
7
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- Preserved left ventricular ejection fraction (LVEF 250%)
- 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 270 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Brest University Hospital
Brest, Finistère, France, 29200
Actively Recruiting
2
Rennes University Hospital
Rennes, Ille-et-Vilaine, France, 35033
Actively Recruiting
3
Tours University Hospital
Tours, Indre-et-Loire, France, 37044
Actively Recruiting
4
Nantes University Hospital
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
5
Clermont Ferrand University Hospital
Clermont-Ferrand, Puy-de-Dôme, France, 63003
Not Yet Recruiting
6
Rouen University Hospital
Rouen, Seine-Maritime, France, 76031
Actively Recruiting
7
Poitiers University Hospital
Poitiers, Vienne, France, 86021
Actively Recruiting
Research Team
R
Research and Innovation Departement of Nantes UH
CONTACT
D
Damien MINOIS, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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