A clinical EValuation of hEmodynamic peRformancE of Trifectaâ?¢ valve in Indian SubjecTs - EVEREST

St Jude Medical India Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subject successfully implanted with SJM TrifectaTM Valve within the last 7 days.
•2. Subject (or legal guardian) has given written informed consent for participation prior to enrollment
•3. Subject is willing to undergo all study procedures and adhere to data collection and follow-up requirements
•4. Subject has adequate echocardiographic images to measure hemodynamic performance of the SJM TrifectaTM valve.

•1. Subject requires replacement of the mitral, tricuspid or pulmonary valve or has a pre-existing prosthetic valve
•2. Subject undergoing renal dialysis
•3. Subject has an active endocarditis (Subjects with previous endocarditis must have two documented negative blood culture results prior to enrollment)
•4. Subject is currently participating in the study of an clinical investigational drug or device
•5. Preoperative evaluation indicated other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
•6. Subject is pregnant or planning to become pregnant during the study period.

发起方

St Jude Medical India Pvt Ltd