REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

NCT07462624 · tracked via the Priya Life Science Germany tracker

Sponsor

Heart Center Leipzig - University Hospital

Phase

Not applicable

Started

2025-11-10

Last updated

2026-03-10

Condition(s) studied

Degenerative Aortic Valve Disease

Investigational drug(s) / intervention(s)

Transfemoral transcatheter valve-in-valve implantationSurgical redo aortic valve replacement

Transfemoral transcatheter valve-in-valve implantation: The intervention under investigation is transcatheter \- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.

Surgical redo aortic valve replacement: Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

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 reintervention at 5 years. — 5 years
based on VARC-3

Trial sites (1)

Facility	City	Region	Status
Herzzentrum Leipzig GmbH	Leipzig	Saxony	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07462624 on ClinicalTrials.gov ↗ ← All trials in Germany