RecruitingNCT06777368
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Sponsor
Medtronic Cardiovascular
Enrollment
225 participants
Start Date
Feb 6, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Eligibility
Min Age: 18 YearsMax Age: 105 Years
Inclusion Criteria1
- BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
Exclusion Criteria6
- BVF due solely to paravalvular 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
- Participating in another study that may influence the outcome of this study
Interventions
DEVICEMedtronic TAV
Medtronic TAV where commercially available
DEVICEEdwards TAV
Edwards TAV where commercially available.
Locations(70)
View Full Details on ClinicalTrials.gov
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NCT06777368
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