Clinical Investigation of the Freedom SOLO stentless Heart valve - SOLO study

Sorin Biomedica CRM SR0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年6月24日

试验速览

暂无简介。

•Patient with pre operative evaluation indicated the need for native or prosthetic aortic valve replacement.
•Any patient amenable to aortic valve replacement with biologcal prothesis, even in conjuction with valve repair, CABG and other procedures.
•Patient will be available to investigator for post-operative follow up beyond one year.

•Patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
•Patient requires a double or triple valve replacement.
•Patient had previously implanted SOLO valve within th clinical study that requires replacement.
•Patient has major or progressive non-cardiac disease that, in the investigator's experience results in life expectancy of less than 1 year or the implant of the device produces an unacceptable increased risk to the patient.
•Patients with congenital bicuspid aortic valve.
•Patient has active endocarditis.

发起方

Sorin Biomedica CRM SR