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Cardiomyopathy Trial - CAT
Description:
Prophylactic ICDs for 1-year mortality and need for transplant in cardiomyopathy.
Hypothesis:
Prophylactic implantation of an ICD would reduce total 1-year mortality by 6%, with a statistical alpha error of 0.05 and a beta error of 0.2.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 20
Mean Follow Up: Goal is 24 months
Mean Patient Age: Not available
Patient Populations:
Dilated cardiomyopathy (left ventricular ejection fraction < 30% at angiography).
NYHA Class II or III heart failure.
Men and women, age > 18 < 70 years.
No symptomatic ventricular arrhythmias (asymptomatic nonsustained ventricular tachycardia not excluded).
Exclusions:
Diagnosis known for > 9 months
Significant coronary artery disease (stenosis > 70%)
Heart transplantation expected within 6 months
NYHA Class I or IV heart failure
Primary Endpoints:
Total mortality
Sudden cardiac death
Secondary Endpoints:
Heart transplantation
Survival of cardiac arrest
Sustained ventricular tachycardia
Symptomatic ventricular arrhythmias requiring antiarrhythmic treatment
Drug/Procedures Used:
ICD, implanted transvenously, used with a subcutaneous patch electrode.
Programmed for maximum heart rate of 200 bpm.
Initial and all subsequent shocks programmed to 30 J with a 5-second delay and a detection rate for VF at 30 bpm higher than maximal heart rate.
Concomitant Medications:
Not stated
Principal Findings:
Not available
Interpretation:
Not available
References:
1. PACE 1992:15:697-700.
2. PACE 1993;16:576-81.
Keywords: Tachycardia, Ventricular, Ventricular Fibrillation, Heart Failure, Stroke Volume, Heart Rate, Defibrillators, Implantable, Cardiomyopathy, Dilated
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