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

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Left Bundle-Branch Block
• Intervention / Treatment: Device: Pacemaker implant; Device: Transcutaneous cardiac monitor

Detailed Description

The study population consists of pacemaker-free patients that are 18 years or older undergoing a TAVI with new onset left bundle branch block. Patient consent is required.

Patients meeting the inclusion criteria will be randomized in a 1:1 ratio to one of the following two groups:

Group 1: electrophysiology-based algorithmic approach

Group 2: standard clinical follow-up with transcutaneous cardiac monitoring.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lena Rivard, MD, MSc; Phone Number: 2120 514-376-3330; Email: lena.rivard@umontreal.ca
• Study Contact Backup: Name: Caroline Girard, EP Prof.; Phone Number: 2905 514-376-3330; Email: caroline.girard@icm-mhi.org

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Recruiting
      • Faculty of medicine
      • Contact: lena Rivard, MD, MSc; Phone Number: 2120 514-376-3330; Email: lena.rivard@umontreal.ca
      • Contact: Caroline Girard; Phone Number: 4058 514-376-3330; Email: caroline.girard@icm-mhi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with cardiovascular hospitalizations.	This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.	12 months
Number of participants with hospitalisations (Total)	This is the number of participants who were hospitalized one-year post-TAVI.	12 months
Number of participants with emergency visits.	This is the number of participants who had emergency visits after TAVI.	12 months
Number of participants experiencing syncope	This is the number of participants who experienced syncope after TAVI.	12 months
Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].	This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other.	12 months
Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.	This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days.	30 days
Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.	This is the number of atrio-ventricular blocks in the EP-guided procedure group compared to the transcutaneous cardiac monitoring group within 12 months of TAVI	12 months

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Investigators: Principal Investigator: Léna Rivard, MD, MSC, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiac Conduction System Disease; Heart Block; Aortic Valve Stenosis; Bundle-Branch Block
• Other Study ID Numbers: ICM#2015-1949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No