NCT07462624

REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 890 (estimated)
• Sponsor: Heart Center Leipzig - University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Aortic Valve Disease

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2025-11-10
• Primary completion: 2033-09-30
• Completion: 2033-09-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Germany