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

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 - REPEAT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034170

Enrollment

850

Registered

2025-09-25

Start date

2025-10-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I35

Interventions

Group 1: transcatheter - preferably transfemoral ViV-TAVR Group 2: surgical rAVR

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or transprosthetic insufficiency); 2. Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of 18 and < 75 years; 4. Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team

Exclusion criteria

Exclusion criteria: 1. Multiple valvular disease requiring surgical intervention; 2. High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment; 3. Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score > 32) and Heart Team assessment that optimal revascularization cannot be performed; 4. Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis); 5. 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); 6. Patients who choose to receive a mechanical AVR.

Design outcomes

Primary

Measure	Time frame
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 re-intervention at 5 years	—

Secondary

Measure	Time frame
1. Each of the individual components of the primary composite endpoint; 2. Valve Academic Research Consortium-3 (VARC-3)-based conduction disturbances and arrhythmia; 3. Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5); 4. New York Heart Association classification III or IV; 5. Health status evaluated by the Kansas City Cardiomyopathy Questionnaire and the SF-36 questionnaire; 6. Six-minute walk test; 7. Treatment Costs per quality adjusted life year Assessment of Safety	—

Measure

Time frame

1. Each of the individual components of the primary composite endpoint; 2. Valve Academic Research Consortium-3 (VARC-3)-based conduction disturbances and arrhythmia; 3. Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5); 4. New York Heart Association classification III or IV; 5. Health status evaluated by the Kansas City Cardiomyopathy Questionnaire and the SF-36 questionnaire; 6. Six-minute walk test; 7. Treatment Costs per quality adjusted life year Assessment of Safety

—

Countries

Germany

Contacts

Public ContactMichael Borger

Herzzentrum Leipzig GmbH

repeat.leipzig@helios-gesundheit.de+49 341 865-1423

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026