TENDyne European expeRience Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 30
- 主要终点
- Rate of procedural success
研究概览
简要总结
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
详细描述
Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.
TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.
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
- •Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
- •Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements
排除标准
- •Patients not providing written informed consent
结局指标
主要结局
Rate of procedural success
时间窗: 30 days
Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure
次要结局
- BNP/NT-proBNP level(30 days, 1 year and 3 years)
- Left and right ventricular dimensions(30 days, 1 year and 3 years)
- Pulmonary artery pressure(30 days, 1 year and 3 years)
- Tricuspid regurgitation severity grade(30 days, 1 year and 3 years)
- Rate of cardiac tamponade(1 day)
- Rate of conversion to open-heart surgery(1 day)
- Rate of procedural mortality(1 day)
- Rate of technical success (cumulative endpoint according to MVARC)(1 day)
- 6-minute walk distance (6MWD)(30 days, 1 year and 3 years)
- Rate of peri-procedural myocardial infarction(1 day)
- Mitral regurgitation severity grade(30 days, 1 year and 3 years)
- Transprosthetic gradient(30 days, 1 year and 3 years)
- New York Heart Association (NYHA) functional class(30 days, 1 year and 3 years)
- Rate of device success (cumulative endpoint according to MVARC)(30 days, 1 year and 3 years)
- Left ventricular function(30 days, 1 year and 3 years)
- Right ventricular function(30 days, 1 year and 3 years)
研究者
Prof. Dr. med. Jörg Hausleiter
Prof. Dr. med. Jörg Hausleiter
LMU Klinikum