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).

Age: 18 Years to 105 Years old

Gender: All

Start Date: 02/06/2025

Primary Completion Date (Estimated): 03/01/2029

Study Completion Date (Estimated): 07/01/2033

Accepts Healthy Volunteers: No

Trial Purpose and 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 Criteria

Age: 18 Years to 105 Years old

Gender: All

Accepts 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