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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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Herzzentrum Leipzig GmbH
RECRUITING
Leipzig
Contact Information
Primary
Michael Borger
Michael.Borger@helios-gesundheit.de
03418650
Backup
Matthias Raschpichler
matthias.raschpichler@helios-gesundheit.de
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2033-09-30
Participants
Target number of participants: 890
Treatments
Experimental: ViV-TAVR
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.
Active_comparator: redoAVR
Surgical redoAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
Sponsors
Collaborators: Helios Health Institute GmbH, University of Leipzig
Leads: Heart Center Leipzig - University Hospital

This content was sourced from clinicaltrials.gov