An observational study in Aortic Stenosis, sponsored by Medtronic Cardiovascular. Recruiting at 71 sites in United States. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Observational
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).
Primary Objectives:
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 225 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects will receive either a Medtronic TAV or Edwards TAV
Device: Medtronic TAV · Device: Edwards TAV
Medtronic TAV where commercially available
Edwards TAV where commercially available.
Primary Outcome Measure
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
Time frame: Early (30-days)
Primary Outcome Measure
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
Time frame: Late (1-year)
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)
(VARC) 3 technical success (at exit from procedure room)
Time frame: Time of procedure
VARC 3 30-day device success
30-day device success
Time frame: 30-Day
VARC 3 30-day early safety
30-day early safety
Time frame: 30-Day
Peak and mean invasive gradient post-procedure
Peak and mean invasive gradient will be measured in mmHg
Time frame: Time of procedure
In-hospital clinical outcomes
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.
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
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.
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
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
Time frame: 5 year
Bioprosthetic Valve Failure (BVF) at the final required follow-up visit
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.
Time frame: Through study completion or Up to 5-years
Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter
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.
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
Evaluate coronary accessibility
Time frame: Up to 30 days
New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter
New York Heart Association (NYHA) classification
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
QoL: KCCQ assessment
Time frame: 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
QoL: EQ5D assessment
Time frame: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
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Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Nov 2027, 33 months after the start.
Of 37 industry-sponsored observational studies under Aortic Valve Stenosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 47. This study's planned 33 months is close to that.
Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
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