← Back to Clinical Trials
Recruiting NCT07462624

REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

Trial Parameters

Condition Degenerative Aortic Valve Disease
Sponsor Heart Center Leipzig - University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 890
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-11-10
Completion 2033-09-30
Interventions
Transfemoral transcatheter valve-in-valve implantationSurgical redo aortic valve replacement

Brief 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 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);

Related Trials