Overview
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
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