Recruiting NCT06777368
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medtronic TAV, Edwards TAV.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: 18 years — 105 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
Detailed 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
Interventions
- Device Medtronic TAV
Medtronic TAV where commercially available - Device Edwards TAV
Edwards TAV where commercially available.
Primary outcome measures
- Primary Outcome Measure [Time frame: Early (30-days)]
- Primary Outcome Measure [Time frame: Late (1-year)]
Secondary outcome measures (12)
- Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room) [Time frame: Time of procedure]
- VARC 3 30-day device success [Time frame: 30-Day]
- VARC 3 30-day early safety [Time frame: 30-Day]
- Peak and mean invasive gradient post-procedure [Time frame: Time of procedure]
- In-hospital clinical outcomes [Time frame: Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)]
- Clinical outcomes at 30 days, 1-year, and annually thereafter [Time frame: 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.]
- Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit [Time frame: 5 year]
- Bioprosthetic Valve Failure (BVF) at the final required follow-up visit [Time frame: Through study completion or Up to 5-years]
- Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter [Time frame: After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.]
- Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days [Time frame: Up to 30 days]
- New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter [Time frame: After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.]
- KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter [Time frame: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 71 centers
- University of Alabama at Birmingham — Birmingham
- Abrazo Arizona Heart Hospital — Phoenix
- Tucson Medical Center — Tucson
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Sutter Heatlh — Sacramento
- Kaiser Permanente Northern California — Sacramento
- Stanford Hospital & Clinics — Stanford
- Los Robles Regional Medical Center — Thousand Oaks
- … and 63 more centers
Identifiers
NCT: NCT06777368 · MDT23040EVR015