I34.0
Conditions
Interventions
Group 1: transthoracic clamping, TC
In case of external cross-clamping a dedicated transthoracic clamp (Chitwood clamp) is passed through a further separate skin incision, usually through the 2nd or 3th intercostal space. The ascending
The IntraClude intra-aortic occlusion device is a triple-lumen, balloon-tipped 10.5 Fr catheter indicated for use in patients undergoing CPB. The IntraClude catheter is inserted through a side branch
Sponsors
Universitätsklinikum Ulm, Kliniken am oberen Eselsberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial Preservation defined by rise of CK-MB (in percent from baseline to maximally observed level) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactAndreas Liebold
Universitätsklinikum Ulm, Klinik für Herz-, Thorax- und Gefäßchirurgie
Outcome results
None listed