DRKS00027353
Recruiting
未知
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 sites340 target enrollmentJanuary 13, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- I34.0
- Sponsor
- niversitätsklinikum Ulm, Kliniken am oberen Eselsberg
- Enrollment
- 340
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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