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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Left Bundle-Branch Block
- Sponsor
- Montreal Heart Institute
- Enrollment
- 250
- Locations
- 10
- Primary Endpoint
- Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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).
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.
Investigators
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
Outcomes
Primary Outcomes
Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
Time Frame: 12 months
This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.
Secondary Outcomes
- Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].(12 months)
- Number of participants with hospitalisations (Total)(12 months)
- Number of participants with emergency visits.(12 months)
- Number of participants with cardiovascular hospitalizations.(12 months)
- Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.(12 months)
- Number of participants experiencing syncope(12 months)
- Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.(30 days)