No phaseRecruitingAge-related condition
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI (COME-TAVI)
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)
- Sponsor
- Montreal Heart Institute (Academic or other)
- Enrollment
- 250 planned
- Conditions
- Left Bundle-Branch Block; Aortic Valve Stenosis
- Interventions
- Pacemaker implant; Transcutaneous cardiac monitor
- Ages
- adults, older adults
- Registry
- NCT03303612
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
History
Primary completion expected
Last registry update
Started
Registered