Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve
Completed
- Conditions
- Failed Transcather Aortic Valve
- Interventions
- Device: TAVR
- Registration Number
- NCT04500964
- Lead Sponsor
- IRCCS Policlinico S. Donato
- Brief Summary
Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR).
The purpouse of this study is to evaluate the indication to a second TAVR, the selection criteria of the second transcatheter aortic valve, procedural and clinical outcomes.
The primary endpoint of the study is overall mortality and Cardiovascular mortality at 1 year
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria
- Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to further transcatheter aortic valve replacement (TAVR).
Exclusion Criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description failed transcather aortic valve (Regurgitation and stenotic)) TAVR - failed transcather aortic valve (Regurgitation) TAVR - failed transcather aortic valve (Stenotic) TAVR -
- Primary Outcome Measures
Name Time Method Overall mortality 1 year Overall mortality and Cardiovascular mortality at 1 year
- Secondary Outcome Measures
Name Time Method VARC-3 Events 1 year Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2).
Trial Locations
- Locations (1)
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Milan, Italy