NCT04818502

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Detailed description

The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting. The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.

Conditions

• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Tendyne™ Mitral Valve System	Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.

Timeline

• Start date: 2021-05-04
• Primary completion: 2025-05-31
• Completion: 2029-05-31
• First posted: 2021-03-26
• Last updated: 2024-06-12

Locations

36 sites across 13 countries: Austria, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Kingdom