FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 638
- 试验地点
- 39
- 主要终点
- All-cause mortality
研究概览
简要总结
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.
The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
详细描述
Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.
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
- •Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
- •High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
- •Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
- •Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
- •Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
- •Preexisting mechanical heart valve in aortic position
- •Ongoing sepsis, including active endocarditis
- •Anatomically not suitable for the Evolut™ PRO system
- •Estimated life expectancy of less than 1 year
- •Participating in another trial that may influence the outcome of this study
- •Need for emergency surgery for any reason
- •Inability to understand and respond to the quality of life questionnaire
结局指标
主要结局
All-cause mortality
时间窗: 30 days post procedure
The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%.
次要结局
- Individual components of the VARC-2 composite safety endpoint(through 5 years from enrollment until end of study)
- Hemodynamic performance(24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post)
- Device success rate(24 hours to 7 days post procedure (prior to discharge))
- Change in NYHA functional status(From baseline to 30-day, 1-year, 3-year, and 5-year post procedure)
- Total AR(24 hours to 7 days post procedure (prior to discharge))
- Rate of new permanent pacemaker implant(30 days post procedure)
- VARC-2 composite safety endpoint(through 5 years from enrollment until end of study)
- Change in Quality of Life score(From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure)