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

Mitral Valve Regurgitation Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04818502
Study type Observational
Source Abbott Medical Devices
Contact
Status Active, not recruiting
Phase
Start date May 4, 2021
Completion date May 31, 2029
View Details
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