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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Left Bundle-Branch Block
    Aortic Valve Stenosis

NCT03303612

Montreal Heart Institute

19 May 2025

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