ZEro Pacemaker Implantation Sutureless Aortic Valve Replacement Study - ZEPIS-AVR Study

Tabata Minoru0 个研究点目标入组 80 人开始时间: 2023年6月16日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients undergoing aortic valve replacement using the Perceval bioprosthetic valve for aortic stenosis or aortic stenosis cum regurgitation at institutions participating in this study will be eligible.
•Selection Criteria
•(1) Age 18 years or older at the time of consent
•(2) Patients with aortic valve disease that can be treated with the commercially available Perceval bioprosthetic valve as determined by preoperative CT scan or transesophageal echocardiography.
•3) Patients who are judged to be suitable for Perceval bioprosthetic valve based on their age, general condition, and comorbidities.
•(iv) Patients who are eligible for 30-day postoperative follow-up
•(5) Patients who have received a thorough explanation of their participation in this study, and who have given their free and voluntary written consent based on a thorough understanding of the study.

•Exclusion Criteria
•(1) Patients undergoing concomitant surgery other than coronary artery bypass surgery
•(2) Patients undergoing preoperative pacemaker (including implantable cardioverter defibrillator) implantation
•(3) Patients with a preoperative diagnosis of chronic atrial fibrillation or atrioventricular block of two or more degrees
•(4) Patients with a contraindication to Perceval bioprosthetic valve treatment in the package insert
•(5) Patients with congenital bicuspid aortic valve (Sievers type 0) or unicuspid aortic valve
•(6) Patients with aortic aneurysm or dissection of the ascending aorta
•(vii) Patients with active endocarditis, myocarditis, or sepsis
•(viii) If the subject is already participating in another clinical trial that may confound the results of this study
•(ix) Other cases in which the principal investigator determines that the subject is inappropriate as a research subject.

发起方

Tabata Minoru