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Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
Sponsor: Montreal Heart Institute
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
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.
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