NCT04161079已完成不适用
Evaluation of the 5-Year Safety and Performance of the Medtentia Annuloplasty Ring in Adults - Follow-Up to Clinical Investigation 2010-040
Medtentia International Ltd Oy1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
研究概览
简要总结
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June 2011 - April 2016.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form.
- •Subject had a successful MAR implantation in clinical investigation 2010-
- •Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan.
排除标准
- •Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system.
结局指标
主要结局
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
时间窗: from 2-year follow-up data point to more than 5 years post-procedure
Success will be defined as no change or any improvement in MR class as described in the American College of Cardiology/ American Heart Association (ACC/AHA) Guidelines
Safety: the Occurrence, Nature and Frequency of Significant Medical Events
时间窗: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
次要结局
- Safety: All-Cause Mortality(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
- Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
- Safety: Number of Cardiovascular Admissions(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
- Safety: the Number of Subjects With Clinically Significant Abnormal Findings(day of study visit)
- Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
- Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
- Performance: Number of Subjects With Recurrence of Mitral Regurgitation(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
- Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE(since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure)
研究者
研究点 (1)
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