NCT06777368RecruitingNot Applicable
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Medtronic Cardiovascular126 sites in 1 country225 target enrollmentStarted: February 6, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 225
- Locations
- 126
- Primary Endpoint
- Primary Outcome Measure
Study Overview
Brief 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).
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 105 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)
Subjects will receive either a Medtronic TAV or Edwards TAV
Intervention: Medtronic TAV (Device)
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)
Subjects will receive either a Medtronic TAV or Edwards TAV
Intervention: Edwards TAV (Device)
Outcomes
Primary Outcomes
Primary Outcome Measure
Time Frame: Early (30-days)
30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device
Primary Outcome Measure
Time Frame: Late (1-year)
a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes
Secondary Outcomes
- VARC 3 30-day device success(30-Day)
- Peak and mean invasive gradient post-procedure(Time of procedure)
- Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit(5 year)
- Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days(Up to 30 days)
- Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)(Time of procedure)
- VARC 3 30-day early safety(30-Day)
- In-hospital clinical outcomes(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(30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.)
- Bioprosthetic Valve Failure (BVF) at the final required follow-up visit(Through study completion or Up to 5-years)
- KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter(At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.)
- EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter(At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.)
- Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter(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.)
- New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter(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.)
Investigators
Study Sites (126)
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