PASTE: PASCAL for Tricuspid Regurgitation - a European Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 14
- 主要终点
- Change of TR severity
研究概览
简要总结
This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in an observational fashion.
详细描述
Tricuspid regurgitation (TR) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. As a consequence, transcatheter treatment techniques have evolved over the last years. Leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated TR treatment. The PASCAL (Edwards Lifesciences, Irvine, USA) offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. The hitherto evidence is mainly based on compassionate use data. This study aims to report the first commercial use in a multicenter study with a large patient cohort und long-term follow-up.
Aim of the study is to investigate safety and efficacy of the PASCAL leaflet repair system in the treatment of TR in a commercial use setting.
Study design is a multicenter, single-device, retro- and prospective, observational registry. All consecutive patients undergoing treatment with the PASCAL system for tricuspid regurgitation in a commercial setting are included.
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 PASCAL system for tricuspid regurgitation in a commercial setting
排除标准
- •Patient age < 18 years
结局指标
主要结局
Change of TR severity
时间窗: 1 year
TR ≤ grade 2+ (moderate)
次要结局
- 6-minute walk distance (6MWD)(1 year)
- Rate of procedural safety(1 week)
- pulmonary artery pressure (PAP)(1 year)
- Rate of technical success(1 day)
- New York Heart Association (NYHA) functional class(1 year)
- right heart dimension(1 year)
- transtricuspid gradient(1 year)
- inferior vena cava (IVC) dimension(1 year)
- NT-proBNP level(last available follow-up (at least 1 year after intervention))
- tricuspid regurgitation severity(last available follow-up (at least 1 year after intervention))
- right heart function(1 year)
研究者
Prof. Dr. med. Jörg Hausleiter
Deputy chief
LMU Klinikum