Status:
RECRUITING
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
Lead Sponsor:
Montreal Heart Institute
Conditions:
Left Bundle-Branch Block
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 inclus...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Informed consent to participate
- Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03303612
Start Date
October 15 2017
End Date
December 1 2026
Last Update
May 8 2025
Active Locations (10)
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1
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
2
New Brunswick Heart Center
Saint John, New Brunswick, Canada
3
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
4
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada