A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points
研究概览
简要总结
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.
详细描述
TREAT TR is a prospective, observational, single-arm, multi-center, post-market study designed to confirm the safety and performance of the TriClip System in a contemporary, real-world setting in accordance with its approved indications for use. The study will be conducted at up to 100 centers globally. Clinical investigation assessments will be conducted prior to the procedure to assess eligibility. Follow-up visits after the TriClip procedure will occur at discharge, 30 days, 6 months (telephone), 12 months, and annually through 5-years. An independent echocardiographic core laboratory (ECL) will be utilized for evaluating echocardiograms. An imaging substudy will be conducted at a subset of participating sites in up to 250 subjects who consent to participate in the substudy. Cardiac-gated computed tomography (CT) will be performed at baseline and 12 months to evaluate reverse cardiac remodeling.
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
- •Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
- •Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
- •Subject agrees to attend follow-up assessments.
- •Subject is ≥ 18 years of age (or legal age of consent) at time of consent.
排除标准
- •Subject is participating in another clinical study that could impact the follow-up or results of this study.
- •Subject has an existing TriClip implant
- •Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.
结局指标
主要结局
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points
时间窗: At 30-day follow-up
All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.
Tricuspid Regurgitation (TR) grade less than or equal to moderate
时间窗: At 30-day follow-up
次要结局
未报告次要终点