Last updated on February 2018

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

Brief description of study

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).

Clinical Study Identifier: NCT02098772

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Gabor Szabo, Prof. Dr. med.

Klinik f r Herzchirurgie, Universit tsklinikum Heidelberg
Heidelberg, Germany
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Ardawan Rastan, Dr. med.

Klinik f r Herz- und Gef chirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg
Rotenburg an der Fulda, Germany
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Klinik f r Herzchirurgie Universit t Leipzig/ Herzzentrum Leipzig
Leipzig, Germany
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Thorsten Doenst, Prof. Dr. med.

Klinik f r Herz- und Thoraxchirurgie Universit tsklinikum Jena
Jena, Germany
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Rüdiger Autschbach, Prof. Dr. med.

Klinik f r Thorax-, Herz- und Gef chirurgie, Uniklinik der RWTH Aachen
Aachen, Germany
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Florian Wagner, Dr. med.

Klinik f r Gef chirurgie, Universit res Herzzentrum am UKE Hamburg
Hamburg, Germany
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