Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI (COME-TAVI)

  • STATUS
    Recruiting
  • End date
    Dec 18, 2024
  • participants needed
    200
  • sponsor
    Montreal Heart Institute
Updated on 7 October 2022
fibrillation
transcatheter aortic valve implantation
tavi
syncope

Summary

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

Description

The study population consists of pacemaker-free patients that are 18 years or older undergoing a TAVI with new onset left bundle branch block. Patient consent is required.

Patients meeting the inclusion criteria will be randomized in a 1:1 ratio to one of the following two groups:

Group 1: electrophysiology-based algorithmic approach

Group 2: standard clinical follow-up with transcutaneous cardiac monitoring.

Details
Condition Left Bundle-Branch Block, Aortic Valve Stenosis
Treatment Pacemaker implant, Transcutaneous cardiac monitor
Clinical Study IdentifierNCT03303612
SponsorMontreal Heart Institute
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years
Informed consent to participate
Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

Exclusion Criteria

Prior pacemaker or implantable cardioverter-defibrillator
Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)
Class I or IIA indication for PPM implantation according to management guidelines
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