Repeat treatment options for failed surgical bioprosthetic aortic valves: redo surgery versus valve-in-valve
Official title: 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
Run by Heart Center Leipzig - University Hospital · NCT07462624 · Data updated 2026-11-12
This trial will test whether redo open-heart aortic valve replacement or a transfemoral valve-in-valve catheter procedure gives better five-year outcomes for adults under 75 with failed surgical bioprosthetic aortic valves and low-to-intermediate surgical risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 890 (estimated) |
| Sponsor | Heart Center Leipzig - University Hospital Academic / other |
| Locations | 1 site (Leipzig, Saxony) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | September 30, 2033 |
| Study ends | September 30, 2033 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07462624 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 and under 75 with structural deterioration of a surgical aortic bioprosthesis, a low-to-intermediate STS surgical risk (<8%), and for whom both redo surgery and ViV-TAVR are judged reasonable by the Heart Team.
✕Probably not a fit
Patients unlikely to benefit include those with multiple valvular disease requiring surgery, active endocarditis or non-structural valve problems, complex or unprotected coronary disease requiring revascularization, high risk of coronary obstruction with ViV-TAVR, or those at high surgical risk or outside the age range.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares two treatment strategies for structural deterioration of surgical aortic bioprostheses: redo surgical aortic valve replacement (rAVR) and transfemoral valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). Participants receive one of the two procedures and are followed for five years to measure a composite endpoint of all-cause mortality, stroke, myocardial infarction, rehospitalization for heart failure, or aortic valve re-intervention. Eligible patients are adults aged >18 and <75 with SVD of a surgical bioprosthesis and an STS predicted risk of mortality <8%, where both approaches are considered reasonable by the local Heart Team. The study is conducted at the Heart Center Leipzig and collaborators include University of Leipzig and Helios Health Institute.
Why it matters
Potential benefit: If successful, the study could identify which approach provides better long-term survival and fewer serious complications for patients with failed surgical bioprosthetic aortic valves.
How similar studies have gone: Observational and registry data show promising short- and mid-term outcomes with valve-in-valve TAVR, but randomized head-to-head evidence comparing ViV-TAVR with redo surgical AVR is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany Recruiting
Study contacts
- Principal investigator: Michael Borger — University Leipzig
- Study coordinator: Michael Borger
- Email: Michael.Borger@helios-gesundheit.de
- Phone: 03418650
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.