The Medtronic CoreValve™ Evolut R™ FORWARD Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,060
- 试验地点
- 54
- 主要终点
- All-cause mortality rate
研究概览
简要总结
Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.
详细描述
The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.
Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.
Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.
Approximately 1000 implanted subjects, consented for follow-up through three years.
For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.
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
- •Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context
- •Age ≥80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:
- •Society of Thoracic Surgeons (STS) predicted risk of mortality ≥8% OR
- •Documented heart team agreement of risk for AVR due to frailty or comorbidities.
- •Geographically stable and willing to return to the implanting site for all follow-up visits
- •Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial
- •The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.
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 R system
- •Estimated life expectancy of less than 1 year
- •Participating in another trial that may influence the outcome of this trial
- •Need for emergency surgery for any reason
结局指标
主要结局
All-cause mortality rate
时间窗: 30 days post implant
All-cause mortality rate at 30 days post procedure
次要结局
- Rate of new permanent pacemaker implant(30 days post implant)
- Device success according to VARC2(24h to 7 days post implant)
- Early safety composite endpoint according to VARC2(30 days post implant)
- Hemodynamic performance(24h to 7 days and 1 year post implant)
- Event rates according to VARC2(30 days post implant)