A prospective, multi-centre, single arm, pivotal clinical study to determine the safety and effectiveness of Triumvir (Dry Transcatheter Aortic Valve Replacement) for use as a Replacement Aortic Heart Valve.

Onecrea Medical India Pvt Ltd.6 个研究点分布在 1 个国家目标入组 15 人开始时间: 2025年3月1日最近更新: 2026年4月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 15
试验地点: 6
主要终点: Safety Endpoint is evaluated by

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate safety and performance outcomes following treatment with the study device in subjects at high surgical risk, as determined by the heart team who require replacement of their native aortic valve due to symptomatic, severe, aortic valve stenosis (AS). High surgical risk is defined as predicted risk of surgical mortality 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator. The total planned study duration is 20 months, which includes an initial recruitment period of 6 months and follow-up period of 12 months and 02-months time for post study analysis and site close outs. However, if the planned recruitment is not completed within the initial 6 months, the recruitment period will be prolonged until the planned recruitment is completed.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Male or female at least 18 years of age.
•Patient provides written informed consent and agrees to all follow-up visits.
•Patients life expectancy at least 1 year.
•subjects with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure who are judged by a heart team, including a cardiac surgeon, to be at high or high risk for open surgical therapy.
•Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use.
•Bicuspid aortic valve can be included at the discretion of the Physician team.

排除标准

•Patients with Mechanical valve in the aortic position.
•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.
•Known allergy to any device component.
•Ongoing sepsis, including active endocarditis
•Patient expected to undergo for coronary intervention within 12 Months.