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

NCT03303612 | Recruiting DMC

• 1 other identifier: ICM#2015-1949
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.

  This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.

  12 months

Secondary Outcomes (7)

• Number of participants with cardiovascular hospitalizations.

  12 months

• Number of participants with hospitalisations (Total)

  12 months

• Number of participants with emergency visits.

  12 months

• Number of participants experiencing syncope

  12 months

• Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].

  12 months

Study Arms (2)

EP-based approach/pacemaker implant

OTHER

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.

Device: Pacemaker implant

Compared transcutaneous cardiac monitor

OTHER

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.

Device: Transcutaneous cardiac monitor

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.

EP-based approach/pacemaker implant

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;

Compared transcutaneous cardiac monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Informed consent to participate
• Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (10)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

RECRUITING

New Brunswick Heart Center

Saint John, New Brunswick, Canada

NOT YET RECRUITING

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

RECRUITING

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

RECRUITING

London Health Sciences Center (LHSC)

London, Ontario, Canada

RECRUITING

University of Ottawa Heart Institute (UOHI)

Ottawa, Ontario, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

RECRUITING

CIUSSS du Nord de l'Île de Mtl

Montreal, Quebec, Canada

RECRUITING

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada, J1J 3H5, Canada

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, Cedex 01, France

NOT YET RECRUITING

Related Publications (1)

• Rivard L, Nault I, Krahn AD, Daneault B, Roux JF, Natarajan M, Healey JS, Quadros K, Sandhu RK, Kouz R, Greiss I, Leong-Sit P, Gourraud JB, Ben Ali W, Asgar A, Aguilar M, Bonan R, Cadrin-Tourigny J, Cartier R, Dorval JF, Dubuc M, Durrleman N, Dyrda K, Guerra P, Ibrahim M, Ibrahim R, Macle L, Mondesert B, Moss E, Raymond-Paquin A, Roy D, Tadros R, Thibault B, Talajic M, Nozza A, Guertin MC, Khairy P. Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block. CJC Open. 2023 Jul 13;5(8):611-618. doi: 10.1016/j.cjco.2023.05.009. eCollection 2023 Aug.

  PMID: 37720184 DERIVED

MeSH Terms

Conditions

Bundle-Branch Block; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Léna Rivard, MD, MSC

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Léna Rivard, MD, MSc

CONTACT

514-376-3330; lena.rivard@umontreal.ca

Caroline Girard, EP Prof.

CONTACT

514-376-3330; caroline.girard@icm-mhi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: October 6, 2017
• Study Start: October 15, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9); FR (1)