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

 1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.

 2. Patient is willing and able to comply with all follow-up requirements through five
 years, including study-required testing, medications, and attending all follow-up
 visits.

 3. Patient provides written informed consent prior to any study-specific procedure.

 Exclusion Criteria:

 1. Patient is in another clinical study that may impact the follow-up or results of this
 study.

 2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up
 period.

 3. Patient is under the age of 18 or age of legal consent.

 4. Patient has other anatomic or comorbid conditions, or other medical, social, or
 psychological conditions that, in the investigator's opinion, may limit the subject's
 ability to participate in the clinical study or to comply with follow-up requirements.