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