Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI (COME-TAVI)
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- STATUS
- Recruiting
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- End date
- Dec 18, 2024
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- participants needed
- 200
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- sponsor
- Montreal Heart Institute
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.
Details
| Condition | Left Bundle-Branch Block, Aortic Valve Stenosis |
|---|---|
| Treatment | Pacemaker implant, Transcutaneous cardiac monitor |
| Clinical Study Identifier | NCT03303612 |
| Sponsor | Montreal Heart Institute |
| Last Modified on | 7 October 2022 |
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