European muLtIcentric Solo International Registry - ELISIR

Sorin Biomedica Cardio s.r.l.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•* Patients are male or female 18 years old or older;
•* Patients are willing to sign the informed consent;
•* Patients which preoperative evaluation indicated the need for native aortic valve replacement;
•* A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve according to the current medical practice for valve selection at the centre.

•* Patients with severe evolving systemic diseases which could compromise the regular control visits or determine life expectancy minor than the duration of the study;
•* Patients with ejection fraction < 30%;
•* Patients with collagenophatic autoimmune disease;
•* Patients affected by disorder of calcium metabolism;
•* Patients with congenital malformation (bicuspid aortic valve);
•* Patients with evident coronary ostia and Valsalva sinuses asymmetry;
•* Patients currently participating in the study of an investigational drug or device;
•* Patients who are drug abusers, alcohol abuser or unable to give informed consent;
•* Patients who are HIV positive;
•* Patients with active endocarditis;
•* Patients required double valve replacement;
•* Patients are known to be noncompliant or are unlikely to complete the study;
•* Any other case in which SOLO valve is not indicated.

发起方

Sorin Biomedica Cardio s.r.l.