Managing new left bundle branch block after transcatheter aortic valve implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital de la Timone - APHM
  Marseille, France Recruiting

Study contacts

• Study coordinator: Baptiste MAILLE, MD
• Email: baptiste.maille@ap-hm.fr
• Phone: 491386576

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Left bundle branch area pacing with multimodal guidance vs. conventional pacing for heart failure with complete left bundle branch block

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• ML-based diagnosis of blocked arteries in patients with a left bundle branch block

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• Using ultra‑high‑frequency ECG to distinguish true LBBB and guide whether left bundle branch or biventricular pacing is best

  We will test whether ultra‑high‑frequency ECG can tell 'true' left bundle branch block from other intraventricular conduction delays and see if people with heart failure and a wide non‑RBBB QRS do better with left bundle branch pacing than with biventricular pacing.

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• Evaluating different approaches to cardiac pacing in patients

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• Mapping the Left Bundle Branch Area for Pacemaker Placement

  This study is testing how using 3D mapping technology during pacemaker placement can help doctors understand the heart's Left Bundle Branch Area better and improve the success of the procedure for patients.

  Recruiting Steward St. Elizabeth's Medical Center of Boston, Inc. · Boston, Massachusetts · NCT05884359

• Comparing Biventricular Pacing and Left Bundle Branch Pacing for Heart Failure

  This study is testing whether a new way of pacing the heart can help people with heart failure feel better and improve their heart function compared to the standard method.

  Recruiting Tomsk National Research Medical Center of the Russian Academy of Sciences · Tomsk · NCT05769036

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.