REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
REpeat Intervention for Failed Surgical BioProsthEtic AorTic Valves (REPEAT): A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve-in-Valve Transcatheter Aortic Valve Replacement
Heart Center Leipzig - University Hospital
890 participants
Nov 10, 2025
INTERVENTIONAL
Conditions
Summary
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.
Eligibility
Inclusion Criteria4
- Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or transprosthetic insufficiency);
- Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of < 8%);
- Age > 18 and < 75 years;
- Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team
Exclusion Criteria6
- Multiple valvular disease requiring surgical intervention;
- High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment;
- Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score > 32) and Heart Team assessment that optimal revascularization cannot be performed;
- Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis);
- Increased post-procedural gradients (mean > 20 mmHg) or severe patient-prosthesis mismatch (PPM, indexed effective orifice area < 0.65 cm2/m2) at discharge from index aortic valve replacement (AVR) procedure;
- Patients who choose to receive a mechanical AVR.
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Interventions
The intervention under investigation is transcatheter \- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.
Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07462624