Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 54
- 主要终点
- Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation
研究概览
简要总结
The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
详细描述
The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.
Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
- •Subject is of legal age in the country where the subject is enrolled.
- •Subject must be willing and able to provide written informed consent to participate in this study.
- •Subject must be willing and able to comply with all follow-up requirements.
排除标准
- •Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
- •Subject has contraindication for cardiac surgery.
- •Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
- •Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
- •Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
- •Subject is undergoing renal dialysis.
- •Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
- •Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
- •Subject has a left ventricular ejection fraction < 30%.
- •Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
- •Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- •Subject has a life expectancy less than 2 years.
结局指标
主要结局
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation
时间窗: 5 years post implant
Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.
次要结局
未报告次要终点