REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
Germany890 participantsStarted 2025-11-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years.