NCT05601453

The ReTAVI Prospective Observational Registry

Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.

Detailed description

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation \[1-3\]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant. Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes \[4\]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation. Currently, \~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Conditions

• Structural Valve Deterioration
• Structural Valve Degeneration
• Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
• Prosthetic Valve Malfunction
• Prosthesis Failure

Interventions

Type	Name	Description
PROCEDURE	Elective redo transcatheter aortic valve implantation (redo-TAVI)	Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)

Timeline

• Start date: 2023-09-05
• Primary completion: 2026-12-01
• Completion: 2031-12-01
• First posted: 2022-11-01
• Last updated: 2025-08-20

Locations

62 sites across 11 countries: Austria, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, Switzerland