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

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

Detailed Description
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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.

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

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Tendyne™ Mitral Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use. 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. Patient provides written informed consent prior to any study-specific procedure. Exclusion Criteria: Patient is in another clinical study that may impact the follow-up or results of this study. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period. Patient is under the age of 18 or age of legal consent. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint for MR Elimination at 1 Year | The primary endpoint MR Elimination will be assessed at one year post-procedure and is defined as original Tendyne valve remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and MR < Grade I (mild, measured by Echocardiographic Core Lab) | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Safety (PS) | This will be assessed at exit from the procedure room and is defined as freedom from procedural mortality, unplanned surgical or interventional procedures related to the Tendyne valve or access procedure. | Day 0, at exit procedure room | 
| Freedom from LVOT Obstruction (LVOTO) at 30 Days | This will be assessed at 30 days post-procedure and is defined as mean LVOT gradient increase <10 mmHg from baseline (measured by the Echo Core Lab), and free of unplanned intervention for LVOTO. | At Day 30 | 
| Freedom from Paravalvular Leak (PVL) at 30 Days | This will be assessed at 30 days post-procedure and is defined as the Tendyne prosthesis PVL ≤ mild (Grade I), as measured by the Echo Core Lab. | At Day 30 | 
| Left Ventricle Reverse Remodeling at 1 Year | This will be assessed at 1-year post-procedure and is defined as the proportion of survivors at one year with baseline Left Ventricle End Diastolic Volume Index (LVEDVi) > 96ml/m2 that experience 10% or greater reduction in LVEDVi at one year (assessed by the Echo Core lab). | At 1 Year | 
| All-Cause Mortality at 30 Days | This will be assessed at 30 days post-procedure and is defined as the proportion of subjects who die within 30 days post-procedure for any cause. | At Day 30 | 
| Long-term Device Durability (LDD) at 5 Years | This will be assessed at 5 years post-procedure and is defined as original Tendyne device remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and free from Structural Valve Dysfunction | At 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Mitral Valve Implantation, Transcatheter Mitral Valve Replacement, Transapical Transcatheter Mitral Valve Implantation, Tendyne Mitral Valve System, Transcatheter, Mitral Regurgitation, Heart Valve disease, Mitral Valve Regurgitation, Mitral Insufficiency, Transcatheter intervention, Tendyne