Outcomes of FIrst and possibility of REdo-TAVI with different transcatheter heart valves
Recruiting
- Conditions
- aortic stenosis
- Registration Number
- DRKS00031563
- Lead Sponsor
- Deutsches Herzzentrum der Charité
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
Patients with aortic regurgitation or stenosis and performed TAVI (01.01.2018-30.09.2022)
Exclusion Criteria
None
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined safety endpoint of all-cause mortality, myocardial infarction, stroke, life-threatening bleeding requiring transfusion, acute kidney injury with need for dialysis, and relevant vascular complications (defined according to the VARC 3 criteria) at discharge from the index hospitalization.
- Secondary Outcome Measures
Name Time Method Procedural outcome (up to discharge from index hospitalization):<br>Cardiovascular mortality<br>Echocardiography post-TAVI: moderate to severe aortic regurgitation, mean preassure gradient<br>Need of a new pacemaker<br>Complications according to Valve Academic Research Consortium (VARC) 3 criteria <br>Neo skirt height as a risk factor for coronary obstruction in case of redo-TAVI<br>Follow-up with regard to survival, hospitalisations and symptoms