Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Abbott Medical Devices
- Enrollment
- 200
- Locations
- 36
- Primary Endpoint
- Primary Endpoint for MR Elimination at 1 Year
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Primary Endpoint for MR Elimination at 1 Year
Time Frame: 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)
Secondary Outcomes
- All-Cause Mortality at 30 Days(At Day 30)
- Procedure Safety (PS)(Day 0, at exit procedure room)
- Freedom from LVOT Obstruction (LVOTO) at 30 Days(At Day 30)
- Freedom from Paravalvular Leak (PVL) at 30 Days(At Day 30)
- Long-term Device Durability (LDD) at 5 Years(At 5 Years)
- Left Ventricle Reverse Remodeling at 1 Year(At 1 Year)