Safety and Effectiveness of Endoaortic Balloon Occlusion as Compared to Transthoracic Clamping for Minimally Invasive Mitral Valve Surgery - SECRET

niversitätsklinikum Ulm, Kliniken am oberen Eselsberg0 个研究点目标入组 340 人开始时间: 2022年1月13日最近更新: 2024年8月19日

适应症

试验速览

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•Clinically significant (moderate-to-severe or severe) mitral regurgitation due to primary (structural) or secondary (functional) pathology with established indication for surgical mitral valve repair or replacement due to ESC/EACTS Guidelines, Patient suited for MIMVS determined by local experience, Patient suited for both BO and TC according to device IFUs, Age = 18, Written informed consent in accordance with Good Clinical Practice (ISO 14155) and current legal regulations

•Ascending aortic aneurysm, Severe aortic insufficiency, Moderate to severe aortic calcification, Thoracic trauma with aortic involvement, Severe tricuspid valve regurgitation requiring intervention, Other severe valve disorders requiring intervention, Relevant coronary artery disease requiring revascularization, Atrial fibrillation requiring surgical ablation, End-stage renal failure requiring dialysis, Severe comorbidities with life expectancy <1 year, Patient not suitable for peripheral CPB cannulation, Diameter of ascending aorta <20 mm and >40 mm, Pregnant or breast-feeding women, Participation in another clinical trial at the same time, Persons held in an institution by legal or official order

发起方

niversitätsklinikum Ulm, Kliniken am oberen Eselsberg