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In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch Block (LBBB) occurring in the context of Transcatheter Aortic Valve Implantation (TAVI), in patients with moderately reduced left ventricular systolic function (35% < EF < 55%). The investigators hypothesize that in patients with persistent LBBB developing after TAVI and mildly reduced left ventricular systolic function (35% < EF < 55%), early postoperative CRT implantation favorably influences the process of myocardial reverse remodeling by reducing electromechanical dyssynchrony, thereby decreasing the combined endpoint of heart failure-related hospitalizations and mortality at one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT | Active Comparator | CRT implantation |
|
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT implantation | Device | CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | Elapsed time to heart failure hospitalisation or all-cause mortality | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (>20%) ventricular pacing
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihály Ruppert | Contact | +3614586810 | merkely.study@gmail.com | |
| Annamaria Kosztin | Contact | kosztin.annamaria@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Bela Merkely | Semmelweis University, Heart and Vascular Center, Budapest, Hungary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University, Heart and Vascular Center | Recruiting | Budapest | 1122 | Hungary |
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