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

Aortic Valve Stenosis Clinical Trial

— COME-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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03303612
• Other study ID #: ICM#2015-1949
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Montreal Heart Institute
• Contact: Léna Rivard, MD, MSc
• Phone: 514-376-3330
• Email: lena.rivard[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bundle-Branch Block
• Left Bundle-Branch Block

Intervention

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.
• 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

Country	Name	City	State
Canada	Faculty of Medicine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants with hospitalisations (Total)	This is the number of participants who were hospitalized one-year post-TAVI.	12 months
Secondary	Number of participants with emergency visits.	This is the number of participants who had emergency visits after TAVI.	12 months
Secondary	Number of participants experiencing syncope	This is the number of participants who experienced syncope after TAVI.	12 months
Secondary	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
Secondary	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
Secondary	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