REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-105
SponsorMedtronic Cardiovascular
About this trial
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 criteria
Qualifiers
BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
Disqualifiers
BVF due solely to paravalvular regurgitation
Active endocarditis
Untreated acute valve thrombosis
Life-expectancy less than 1-year
Trial design
Treatments tested in this trial
- Medtronic TAV
- Edwards TAV
Treatment groups
225 Participants
are divided into 1 treatment groupLocations
71Alabama
University of Alabama at Birmingham35233, Birmingham United States
Arizona
Abrazo Arizona Heart Hospital85016, Phoenix United States
Tucson Medical Center85712, Tucson United States
California
Kaiser Permanente Los Angeles Medical Center90027, Los Angeles United States
Sponsors and collaborators
Medtronic Cardiovascular
Lead sponsor
Source ClinicalTrials.gov