Recruiting

Monitoring Strategy vs. Electrophysiology

Sponsor:

Montreal Heart Institute

Code:

NCT03303612

Conditions

Left Bundle-Branch Block

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pacemaker implant

Transcutaneous cardiac monitor

Study Details

Brief 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).

Conditions

Left Bundle-Branch Block

Aortic Valve Stenosis

Study ID

NCT03303612

Start date

Oct 15, 2017

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: EP-based approach/pacemaker implant

Subjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec.

In the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation.

other: Compared transcutaneous cardiac monitor

Subjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days.

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;

Primary outcome measure

  • Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Mazankowski Alberta Heart Institute

Recruiting

Edmonton, Alberta, Canada

Principal Investigator:

Kenneth Quadros, MD

QEII Health Sciences Center

Recruiting

Halifax, Nova Scotia, Canada

Principal Investigator:

Ratika Parkash, MD

Hamilton Health Sciences Corporation

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Madhu Natarajan, MD

London Health Sciences Center (LHSC)

Recruiting

London, Ontario, Canada

Principal Investigator:

Jaimie Manlucu, MD

University of Ottawa Heart Institute (UOHI)

Recruiting

Ottawa, Ontario, Canada

Principal Investigator:

Mehrdad Golian, MD

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, Canada, J1J 3H5

Principal Investigator:

Benoît Daneault, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T1C8

Contacts

Principal Investigator:

Lena Rivard, MD

CIUSSS du Nord de l'Île de Mtl

Recruiting

Montréal, Quebec, Canada

Principal Investigator:

Rémi Kouz, MD

More Information

Sponsor

Montreal Heart Institute

Last update posted

May 8, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2025-05-08.