Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation

NCT06148883 | Recruiting

• 1 other identifier: 2022-A02699-34
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.

Conditions

Left Bundle-Branch Block

Outcome Measures

Primary Outcomes (1)

• Alive status with appropriate Pacemaker implantation/non-implantation

  The primary endpoint of this study is the alive status with appropriate Pacemaker implantation/non-implantation, at 12 months after randomization. * Appropriate Pacemaker non-implantation: \- Absence of syncope or sudden cardiac death in a non-implanted patient * Appropriate Pacemaker implantation: * Documented indisputable criteria for Pacemaker implantation * Absence of syncope or sudden cardiac death * Absence of upgrading procedure

  12 months

Study Arms (2)

Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge

ACTIVE COMPARATOR

In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring.

Procedure: Transcatheter Aortic Valve Implantation

Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluation

EXPERIMENTAL

In this group, Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms.

Procedure: Transcatheter Aortic Valve Implantation

Interventions

Transcatheter Aortic Valve Implantation PROCEDURE

Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously

Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge; Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :
• 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
• With an anticipated life expectancy \>1 year
• Who consent to participate to the study

You may not qualify if:

• 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
• Prior Pacemaker or Implantable Cardiac defibrillator
• Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator
• Pre-existing Left Bundle Branch Block or Right Bundle Branch Block
• Pre-existing PR interval prolongation \> 240 ms
• Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination \< 15
• Pregnancy or breastfeeding patient
• No affiliation to a social security scheme
• Adult under legal protection (trusteeship, guardianship).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de la Timone - APHM

Marseille, 13385, France

RECRUITING

MeSH Terms

Conditions

Bundle-Branch Block

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Baptiste MAILLE, MD

CONTACT

491386576; baptiste.maille@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open labelled clinical study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized in 2 parallel group study

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: November 12, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)