REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

ID#: NCT06777368

Age: 18 - 105 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: February 06, 2025

End Date: July 01, 2033

Contact Information:
RESTORE Study Clinical Team
763 514 4000
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:



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