Actively Recruiting
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
Led by Heart Center Leipzig - University Hospital · Updated on 2026-03-10
890
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
Sponsors
H
Heart Center Leipzig - University Hospital
Lead Sponsor
U
University of Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (stenosis and/or transprosthetic insufficiency)
- Low to intermediate surgical risk with Society of Thoracic Surgeons predicted risk of mortality less than 8%
- Age greater than 18 and less than 75 years
- Both redo aortic valve replacement and valve-in-valve transcatheter replacement are considered reasonable options by the local Heart Team
You will not qualify if you...
- Multiple valvular disease requiring surgical intervention
- High-risk coronary anatomy increasing risk of coronary obstruction after valve-in-valve procedure
- Complex coronary artery disease needing revascularization that cannot be optimally performed
- Evidence of bacterial endocarditis or non-structural valve deterioration such as paravalvular leak or thrombosis
- Increased post-procedural gradients over 20 mmHg or severe patient-prosthesis mismatch after the initial valve replacement
- Patients opting for mechanical aortic valve replacement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany, 04289
Actively Recruiting
Research Team
M
Michael Borger
CONTACT
M
Matthias Raschpichler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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