Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

Inclusion Criteria:

• Patients >/= 30 and </= 85 years of age
• Male or female with aortic valve disease
• Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
• Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.

Exclusion Criteria:

• History of recent (< 6 weeks) Q-wave myocardial infarction
• Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
• Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
• Pregnant or lactating patients
• Patients who have participated in any other investigational studies within 30 days previous to enrollment
• Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
• Patients with severe chronic obstructive lung disease (FEV1 < 50%)
• Previous cardiac valvular disease (clinical relevant)
• GFR <60 ml/min
• Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale
• Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination
• History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.