NCT03303612

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Left Bundle-Branch Block
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Pacemaker implant	Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.
DEVICE	Transcutaneous cardiac monitor	Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include: Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval \>5 sec; Third-degree AV block or Mobitz 2 AV block;

Timeline

• Start date: 2017-10-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-10-06
• Last updated: 2025-05-08

Locations

10 sites across 2 countries: Canada, France