Managing new left bundle branch block after transcatheter aortic valve implantation

Comparison of Early Ambulatory Monitoring Strategy Versus Electrophysiological Study Approach in the Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation

This compares using a one-month ambulatory ECG after TAVR with doing an immediate electrophysiology study to decide if patients who develop a new, persistent left bundle branch block need a pacemaker.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 1 site (Marseille)
• Trial ID: NCT06148883 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, open-label multicenter trial that enrolls patients who develop a new, persistent left bundle branch block (LBBB >150 ms) after transcatheter aortic valve implantation (TAVR). Eligible patients with stable LBBB persisting at least 48 hours and without high-grade AV block or a prolonged PR interval are randomized 1:1 to either one month of ambulatory ECG monitoring with post-discharge pacemaker decisions or an in-hospital electrophysiology study with pacemaker implantation if the His–ventricular interval is ≥70 ms. Patients are followed for 12 months with in-person visits at 1 and 12 months and telemedicine visits at 3 and 6 months. The primary outcome compares the proportion of patients alive with an appropriate pacemaker implantation or appropriate non-implantation at 12 months.

Who should consider this trial

Good fit: Adults (≥18) who undergo TAVR and develop a new, persistent LBBB (>150 ms) that is stable for at least 48 hours, have anticipated life expectancy >1 year, and have no immediate indications for a pacemaker or prior pacemaker/ICD are ideal candidates.

Not a fit: Patients with documented high-grade AV block, persistent PR interval >240 ms, syncope, clear indications for immediate pacemaker implantation, prior pacemaker/ICD, or an indication for cardiac resynchronization are unlikely to benefit from the randomized comparison.

Why it matters

Potential benefit: If successful, this approach could safely reduce unnecessary early pacemaker implants and shorten hospital stays by using outpatient ECG monitoring to guide decisions.

How similar studies have performed: Observational studies and guideline discussions have examined different management strategies for new LBBB after TAVR, but randomized comparisons of ambulatory monitoring versus electrophysiology-guided decisions are limited.

Eligibility criteria

Inclusion Criteria:

Patients who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :

1. Presenting with New Onset Persistent Left Bundle Branch Block, defined as a new Left Bundle Branch Block \>150 ms that persists at least two days after Transcatheter Aortic Valve Implantation and is stable
2. With an anticipated life expectancy \>1 year
3. Who consent to participate to the study

Exclusion Criteria:

1. During in-hospital Electrocardiogram monitoring period, immediately after Transcatheter Aortic Valve Implantation and before inclusion:

   * Documented high grade Atrio Ventricular block (Atrio Ventricular block of a degree higher than Mobitz I)
   * Persistent PR interval prolongation \> 240 ms
   * Occurrence of syncope or sudden cardiac death,
   * Identification of any indisputable criteria for Pacemaker implantation
   * Definitive Pacemaker implantation
2. Prior Pacemaker or Implantable Cardiac defibrillator
3. Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator
4. Pre-existing Left Bundle Branch Block or Right Bundle Branch Block
5. Pre-existing PR interval prolongation \> 240 ms
6. Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination \< 15
7. Pregnancy or breastfeeding patient
8. No affiliation to a social security scheme
9. Adult under legal protection (trusteeship, guardianship).

Where this trial is running

Marseille

• Hôpital de la Timone - APHM — Marseille, France (Recruiting)

Study contacts

• Study coordinator: Baptiste MAILLE, MD

Conditions Left Bundle-Branch Block