Comparison of two cardiac protections techniques during cardiac surgery

• Conditions: Medical conditions necessitating an elective surgical coronary artery bypass grafting (CABG) and/or a valve repair/replacement.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-016954-42-AT
• Lead Sponsor: Swiss Cardio Technologies AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.The patient is between the age of 18 and 80;
2.The patient’s preoperative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement;
3.The operation is carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine;
4.The patient has signed the Patient Informed Consent Form.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1.pre-operative EF of less than 30%;
2.pre-operative IABP;
3.under pre-operative catecholamine support;
4.history of myocardial infarction within less than 7 days;
5.previous history of cardiac surgery, including the implantation of a pace maker or an ICD;
6.active myocarditis and/or endocarditis;
7.history of atrial fibrillation;
8.aortic valve insufficiency severity grade > 1 ;
9.history of neurologic event;
10.carotid artery disease;
11.renal insufficiency or is under dialysis;
12.pre-operative serum creatinine value of more than 2.0 mg/dl;
13.known for an hematologic disorder;
14.under anti-vitamin K;
15.history of HIT;
16.participating in a concomitant research study of an investigational product;
17.pregnant or lactating;
18.intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified