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REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Recruiting
18-105 years
All
Phase N/A

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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

Study details
    Aortic Stenosis

NCT06777368

Medtronic Cardiovascular

1 November 2025

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