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RECRUITING
NCT03303612
NA

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

Sponsor: Montreal Heart Institute

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2017-10-15

Completion Date

2026-12

Last Updated

2025-05-08

Healthy Volunteers

No

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;

Locations (10)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

New Brunswick Heart Center

Saint John, New Brunswick, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

London Health Sciences Center (LHSC)

London, Ontario, Canada

University of Ottawa Heart Institute (UOHI)

Ottawa, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

CIUSSS du Nord de l'Île de Mtl

Montreal, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada, Canada

Centre Hospitalier Universitaire de Nantes

Nantes, Cedex 01, France