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

Dr. Franz Köhler Chemie GmbH0 个研究点目标入组 530 人开始时间: 2013年4月22日最近更新: 2024年9月9日

适应症

试验速览

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•The study population will be selected from patients of either sex who are to undergo for aortic valve surgery (with and without coronary bypass surgery).
•(1) Patients >/=30 and (2) Male or female with aortic valve disease
•(3) Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
•(4) 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 170
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 190

•(1) History of recent (< 6 weeks) Q-wave myocardial infarction
•(2) Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
•(3) Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
•(4) Pregnant or lactating patients
•(5) Patients who have participated in any other investigational studies within 30 days previous to enrollment
•(6) Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
•(7) Patients with severe chronic obstructive lung disease (FEV1 < 50%)
•(8) Previous cardiac valvular disease (clinical relevant)
•(9) GFR <60 ml/min
•(10) 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
•(11) Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination
•(12) 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.

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