Repeat treatment options for failed surgical bioprosthetic aortic valves: redo surgery versus valve-in-valve

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 890 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Heart Center Leipzig - University Hospital (Academic / other)
• Locations: 1 site (Leipzig, Saxony)
• Trial ID: NCT07462624 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Leipzig, Saxony

• Herzzentrum Leipzig GmbH — Leipzig, Saxony, Germany (Recruiting)

Study contacts

• Principal investigator: Michael Borger — University Leipzig
• Study coordinator: Michael Borger

Conditions Degenerative Aortic Valve Disease