Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 38
- 主要终点
- Primary Endpoint for MR Elimination at 1 Year
研究概览
简要总结
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Endpoint for MR Elimination at 1 Year
时间窗: 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)
次要结局
- 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)