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REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
Sponsor: Heart Center Leipzig - University Hospital
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
890
Start Date
2025-11-10
Completion Date
2033-09-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany