Prospective, non-randomized, two-phase, multicenter Phase IV clinical trial for patients clinically indicated for implantation of a Portico or Navitor transcatheter aortic heart valve - None

Abbott India Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•1.Subject must provide written informed consent prior to any clinical investigation-related procedure.
•2.Are >60 years of age in host country, have severe symptomatic (NYHA class = II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant

•1.Have tested positive for the COVID-19 virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
•2.Have sepsis, including active endocarditis
•3.Have any evidence of left ventricular or atrial thrombus
•4.Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
•5.Have a non-calcified aortic annulus
•6.Have congenital bicuspid or unicuspid leaflet configuration
•7.Are unable to tolerate antiplatelet/anticoagulant therapy
•8.Are pregnant at the time of signing informed consent
•9.Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)

发起方

Abbott India Pvt Ltd