Clinical Trial

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

Study acronym: COME-TAVI
Recruiting
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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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2017-10-05; most recent amendment 2025-05-05.
Trial Details
NCT Number NCT03303612
Lead Sponsor Montreal Heart Institute
Conditions Left Bundle-Branch Block, Aortic Valve Stenosis
Enrollment 250 participants
Start Date 2017-10-15
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-08