ORANGE- TEER (Outcome Registry and Assessment of New Edge-to-Edge Repair)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
研究概览
简要总结
The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR). The main question it aims to answer is:
The patient selection process could be optimized. Participants are already receiving edge-to-edge repair as part of their standard medical care and will additionally complete quality-of-life survey questions.
详细描述
Mitral regurgitation (MR) affects more than 10% of individuals over the age of 75, and with an aging population, its prevalence is expected to continue rising in the coming years. Treatment options include surgical repair, surgical replacement, medical therapy, cardiac resynchronization therapy (CRT), or transcatheter valve repair. For percutaneous mitral valve repair, the transcatheter edge-to-edge repair (M-TEER) technique is the preferred approach. This technique involves the use of the MitraClip (Abbott) and PASCAL (Edwards) devices, which are derived from the surgical Alfieri technique.
Since 2009, the M-TEER procedure has been performed in patients who, based on assessment by the heart team and mitral valve team, are deemed unsuitable for surgery but are eligible for this percutaneous treatment.
Using data from all patients undergoing M-TEER at Amsterdam UMC, the investigators aim to conduct research focused on improving patient selection and alleviating symptoms associated with mitral valve disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Accepted for M-TEER (Minimally Invasive Transcatheter Edge-to-Edge Repair) procedure
排除标准
- •Unable to complete the questionnaires
结局指标
主要结局
Change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: Baseline and 6 months
Change in health-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months. The KCCQ is a validated, disease-specific instrument measuring physical function, symptoms, social limitations, and quality of life in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better health status. Unit of Measure: KCCQ score (0-100)
Change in quality of life measured by the 36-Item Short Form Survey (SF-36)
时间窗: Baseline and 6 months
Change in health-related quality of life as assessed by the 36-Item Short Form Survey (SF-36) from baseline to 6 months. The SF-36 is a validated, generic instrument assessing physical and mental health across 8 domains. Scores are standardized to a 0-100 scale, with higher scores indicating better perceived health. Unit of Measure: SF-36 score (0-100)
次要结局
未报告次要终点
研究者
Abby Geerlings
PhD Candidate, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)