The Efficacy and Safety for Transcatheter Aortic Valve Replacement by Using Self-expandable Device in Dialysis Patients with Severe Aortic Stenosis - The Efficacy and Safety for TAVR by Using Self-expandable Device in Dialysis Patients with Severe Aortic Stenosis

Saito Shigeru0 个研究点目标入组 10 人开始时间: 2020年4月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)The patients with severe aortic stenosis (AS)
•2)The patients have AVA < 1.0 cm2 or EOAi < 0.5 cm2/m2 and Mean PG > 40 mmHg or Peak aortic-jet velocity > 4.0 m/s in transthoratic echocardiograply at rest or dobtamin stress echocardiography.
•3)The patients have symptomatic severe AS with >= NYHA class 2
•4)The patients have high risk for surgical aortic valve replacement in heart team discussion
•5)The patients with dialysis. The patients have performed maintained dialysis >= 1 month as stable.
•6)The patients have performed maintained dialysis including either peritoneal dialysis or hemodialysis.
•7)The patients >= 20 years old and >= 90 years old.
•8)The patients agree this study and write informed consents after they understand this study protocol.

•1) The patients with low ejection fraction (less than 20%).
•2) The patients with myocardial infarction within 30days.
•3) The patients with fresh bleeding.
•4) The patients with cerebral infarction within 6 months.
•5) The patients with hemoglobin < 8.0 g/dl.
•6) The patients with WBC <3000 or PLT < 100000.
•7) The patients with positive HBV or HCV or HIV.
•8) The patients with participate other clinical trial.
•9) The patients with pregnant women (including possible) or lactating women
•10) The patients that research director or contributory members judged inappropriate patients in this study.
•11) The patients with need for emergency operation even if any reason.
•12) The patients who have a life expectancy of less than 12 months due to comorbidities without cardiac disease.

发起方

Saito Shigeru