REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Medtronic Cardiovascular
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).
Description
Primary Objectives: * To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs * To determine the factors which are associated with the acute and long-term outcomes of redo TAVR
Eligibility
- Age range
- 18–105 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR Exclusion Criteria: * 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)
- University of Alabama at BirminghamBirmingham, Alabama
- Abrazo Arizona Heart HospitalPhoenix, Arizona
- Tucson Medical CenterTucson, Arizona
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
- Sutter HeatlhSacramento, California
- Kaiser Permanente Northern CaliforniaSacramento, California