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

Not Applicable

Recruiting

Conditions: I34.0
Mitral (valve) insufficiency

Registration Number: DRKS00027353

Lead Sponsor: niversitätsklinikum Ulm, Kliniken am oberen Eselsberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 340

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial Preservation defined by rise of CK-MB (in percent from baseline to maximally observed level)

Secondary Outcome Measures

Name	Time	Method
Creatin kinase, cardiac troponin t, duration of operation, duration of CPB, duration of aortic occlusion, stability of cardioplegic arrest, restoration of heart rhythm after cardioplegic arrest, drainage blood loss, blood transfusions, time on mechanical ventilation, new onset atrial fibrillation, length of ICU stay, length of hospital stay