Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
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).