REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
- Conditions
- Aortic Stenosis
- Registration Number
- NCT06777368
- Lead Sponsor
- Medtronic Cardiovascular
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 225
- BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measure 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 Outcome Measures
Name Time Method VARC 3 30-day device success 30-Day 30-day device success
Peak and mean invasive gradient post-procedure Time of procedure Peak and mean invasive gradient will be measured in mmHg
Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit 5 year Intrinsic permanent changes to the prosthetic valve, including wear and tear, leaflet disruption, flail leaflet, leaflet fibrosis and/or calcification, or strut fracture or deformation
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 Evaluate coronary accessibility
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room) Time of procedure (VARC) 3 technical success (at exit from procedure room)
VARC 3 30-day early safety 30-Day 30-day early safety
In-hospital clinical outcomes Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days) Percentage of all participants with all-cause mortality, all stroke, Myocardial infarction (MI), Coronary artery obstruction, Unplanned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG), Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, and Valve Thrombosis.
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. All-cause mortality, All stroke, Myocardial infarction (MI), Coronary artery obstruction, Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, Valve Thrombosis, Any rehospitalization and re-intervention.
Bioprosthetic Valve Failure (BVF) at the final required follow-up visit Through study completion or Up to 5-years Any bioprosthetic valve dysfunction associated with clinically expressive criteria (new-onset or worsening symptoms, left ventricle dilation/hypertrophy/dysfunction, or pulmonary hypertension) or irreversible Stage 3 Hemodynamic Valve Deterioration (HVD) or Aortic valve reoperation or re-intervention, or Valve-related death.
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. QoL: KCCQ assessment
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. QoL: EQ5D assessment
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. Left ventricular ejection fraction, mean gradient across aortic valve, effective orifice area, effective orifice area index, patient-prosthesis mismatch, Doppler Velocity Index, total aortic regurgitation, paravalvular aortic regurgitation, and transvalvular aortic regurgitation.
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. New York Heart Association (NYHA) classification
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (41)
Sutter Heatlh
🇺🇸Sacramento, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
MedStar Washington Medical Center
🇺🇸Washington, District of Columbia, United States
MercyOne Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
University of Michigan Health
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Astrium Health Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Providence Heart Institute (Providence Sacred Heart)
🇺🇸Spokane, Washington, United States
Abrazo Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
HealthPark Medical Center, Lee Memorial Health
🇺🇸Fort Myers, Florida, United States
Orlando Health/Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Abbott Northwestern/Minneapolis Heart
🇺🇸Minneapolis, Minnesota, United States
Providence Saint Patrick Hospital
🇺🇸Missoula, Montana, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Medstar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
UPMC Pinnacle
🇺🇸Mechanicsburg, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Aurora St. Lukes Medical Center
🇺🇸Milwaukee, Wisconsin, United States