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

Dr. Franz Köhler Chemie

Status and phase

Completed

Phase 3

Conditions

Aortic Valve Disease

Coronary Artery Disease (CAD)

Treatments

Drug: Custodiol-N

Drug: Custodiol

Study type

Interventional

Funder types

Industry

Identifiers

NCT02098772

CL-N-CSM-AV-III/05/12

Details and patient eligibility

About

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).

Enrollment

530 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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.