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Life sciences · Observational Study
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07885761). This is a study registration, not published results. Lead sponsor: Institut für Pharmakologie und Präventive Medizin. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis, Prosthetic Valve Endocarditis. Interventions: PROCEDURE: TAVI-in-SAVR (Valve-in-Valve); PROCEDURE: THV-in-THV (Redo-TAVI); PROCEDURE: Surgical Explantation of a Failed Transcatheter Heart Valve; OTHER: Medical management. Primary outcome measures: REVIVE-FR Success at 30 Days , 30 days after procedure; Early Safety at 30 Days , 30 days after procedure. Brief summary: This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly. As patients with severe aortic stenosis are increasingly younger and at lower surgical risk, more patients may experience bioprosthetic valve failure during their lifetime. Treatment options include implanting a new valve inside the existing valve using a catheter-based procedure, surgically removing the failed valve, or providing conservative medical treatment. The study will evaluate outcomes associated with these different treatment strategies to improve understanding of their benefits and risks and help guide future treatment decisions for patients with bioprosthetic valve failure.