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

Aortic Valve Stenosis Clinical Trial

Official title:
Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03303612
Study type Interventional
Source Montreal Heart Institute
Contact Léna Rivard, MD, MSc
Phone 514-376-3330
Email lena.rivard@umontreal.ca
Status Recruiting
Phase N/A
Start date October 15, 2017
Completion date December 2026
View Details
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