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REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

RecruitingNAAges 18 Years - 75 YearsAllHeart Center Leipzig - University Hospital
NCT07462624 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transfemoral transcatheter valve-in-valve implantation
  • Surgical redo aortic valve replacement
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Where

1 site
Herzzentrum Leipzig GmbH
Leipzig, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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