NCT06148883

Management of Patients With 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicentric, randomized in parallel group, controlled, open labelled clinical study. * After Transcatheter Aortic Valve Implantation, all consecutive patients presenting with new onset Left Bundle Branch Block will undergo in-hospital telemetry. In case of persistence (at least 48 hours) of a stable (i.e., no change in the last 24 hours) Left Bundle Branch Block \> 150 ms, and in the absence of high grade Aortic Valve block or persistent prolonged PR interval \> 240 ms, patients will be eligible for the study * After written consent will be obtained, included patients will be randomized into two groups according to a 1:1 ratio: * Electrocardiogram Ambulatory Monitoring for 1 month and immediate discharge. In this group, Pacemaker implantation will be decided, after discharge, on documented Electrocardiogram abnormalities obtained from the 1 month Electrocardiogram Ambulatory Monitoring. Any other clinically relevant therapeutic decision based on Electrocardiogram Ambulatory Monitoring will be taken or * ElectroPhysiological Study for infra-hisian conduction evaluation. Pacemaker implantation will be decided, before discharge, in case of prolonged His-Ventricular interval ≥ 70 ms * Patients in both groups will be followed until the end of the first year after randomization. Follow-up visits will be scheduled in person at 1 and 12 months, and through telemedicine at 3 and 6 months. Appropriateness of Pacemaker implantation/non-implantation will be evaluated at each follow-up time * In case of any occurrence of syncope, patients will be evaluated in person, by the principal investigator of each centre, to evaluate and manage the syncope as recommended by the European Society of Cardiology guidelines. Patients will be followed-up according to current practice.

Conditions

• Left Bundle-Branch Block

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Aortic Valve Implantation	Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously

Timeline

• Start date: 2024-11-12
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-11-28
• Last updated: 2025-07-01

Locations

1 site across 1 country: France