Status:
RECRUITING
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Collaborating Sponsors:
Medtronic
NAMSA
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty ao...
Detailed Description
To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves ...
Eligibility Criteria
Inclusion
- 1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
Exclusion
- Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
- Active endocarditis
- Untreated acute valve thrombosis
- Life-expectancy less than 1 year
- Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
- Pregnant or nursing
Key Trial Info
Start Date :
December 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06557798
Start Date
December 12 2024
End Date
March 1 2033
Last Update
January 8 2026
Active Locations (52)
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1
Aalborg Universitethospital
Aalborg, Denmark
2
Århus Universitetshospital
Aarhus, Denmark
3
Rigshospitalet
Copenhagen, Denmark
4
HUS Helsinki University Hospital
Helsinki, Finland