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Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block

RecruitingNAAges 18 Years - anyAllNantes University Hospital
NCT07236489 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, thereb

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Pacemaker implantation using left bundle branch area stimulation
  • Right ventricular pacemaker implantation
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Where

7 sites
Brest University Hospital
Brest, France
Rennes University Hospital
Rennes, France
Tours University Hospital
Tours, France
Nantes University Hospital
Nantes, France
Clermont Ferrand University Hospital
Clermont-Ferrand, France
Rouen University Hospital
Rouen, France
Poitiers University Hospital
Poitiers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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