A prospective, multi-centre, single arm, pivotal clinical study to determine the safety and effectiveness of Crea Aortic Valve for use as a Replacement Aortic Heart Valve - NI

Onecrea Medical India0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1. Male or female at least 18 years of age.
•2. Patient provides written informed consent and agrees to all follow-up.
•3. Patient life expectancy at least 1 year.
•4. 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 greater risk for open surgical therapy.
•5. Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use. The patient’s aortic arch anatomy requirements are as per communication with the Investigator during training. Patient must present the aortic arch of greater than 80 mm diameter or 100 mm shaft should be able to fit in a straight line in the aorta at the arch.

•1. Mechanical or biologic prosthesis in the aortic position.
•2. 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.
•3. Known allergy to any device component.
•4. Bicuspid aortic valve
•5. Ongoing sepsis, including active endocarditis
•6. Pregnant (female of childbearing potential only).
•7. Patient ejection fraction <35%.
•8. Patient expected to undergo for coronary intervention within 12 Months

发起方

Onecrea Medical India