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

NARecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 15, 2017

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Left Bundle-Branch BlockAortic Valve Stenosis
Interventions
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;"

Trial Locations (10)

Unknown

RECRUITING

Mazankowski Alberta Heart Institute, Edmonton

NOT_YET_RECRUITING

New Brunswick Heart Center, Saint John

RECRUITING

QEII Health Sciences Center, Halifax

RECRUITING

Hamilton Health Sciences Corporation, Hamilton

RECRUITING

London Health Sciences Center (LHSC), London

RECRUITING

University of Ottawa Heart Institute (UOHI), Ottawa

RECRUITING

CIUSSS du Nord de l'Île de Mtl, Montreal

NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Nantes, Nantes

H1T1C8

RECRUITING

Montreal Heart Institute, Montreal

J1J 3H5

RECRUITING

Centre hospitalier universitaire de Sherbrooke, Sherbrooke

All Listed Sponsors
lead

Montreal Heart Institute

OTHER