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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


NCT number NCT04818502
Study type Observational
Source Abbott Medical Devices
Contact Bart Janssens
Phone +32471723201
Email bart.janssens@abbott.com
Status Recruiting
Phase
Start date May 4, 2021
Completion date May 31, 2029

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