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

Sponsor: Montreal Heart Institute • ClinicalTrials.gov ID: NCT03303612

Registry updated: 2026-10-14

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Description

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).

Interventions

Pacemaker implant (Device)
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 (Device)
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;

Eligibility criteria

Inclusion Criteria: * Age ≥18 years * Informed consent to participate * Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2) Exclusion Criteria: * Prior pacemaker or implantable cardioverter-defibrillator * Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI) * Class I or IIA indication for PPM implantation according to management guidelines

Conditions

Left Bundle-Branch Block Aortic Valve Stenosis

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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