Structural Heart - RESTORE
Prospective, non-randomized, multi-center, post-market study. The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo TAVR.
To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs.
Criteria:
Inclusion:
- BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
Exclusion:
- BVF due solely to paravalvular regurgitation
- Active endocarditis
- Untreated acute valve thrombosis
- Life-expectancy less than 1-year
Location: Hartford Hospital
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT06777368
Sponsor: Medtronic
Contact: Jadwiga Jerman 860-972-9146 Jadwiga.Jerman@hhchealth.org