Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrill… (NCT01378572) | Clinical Trial Compass
UnknownNot Applicable
Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy
United States, Italy200 participantsStarted 2009-11
Plain-language summary
With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of sudden cardiac death. Moreover, the investigators also aim to identify if there is any electrophysiological substrate modification at the time of the first arrhythmic event in these patients. To this aim, the investigators will prospectively correlate electroanatomic mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who are therefore more likely to benefit from a defibrillator implantation. Furthermore, electroanatomic mapping will be repeated at the time of the first arrhythmic event and compared with that at baseline, in order to evaluate any electrophysiological substrate changes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females ≥18 year-old with full capacity.
✓. A New York Heart Association (NYHA) class II or III chronic, stable congestive heart failure (CHF).
✓. A left ventricular ejection fraction (LVEF) of no more than 35 percent.
Exclusion criteria
✕. Age \<18 years or diminished capacity.
✕. Patients with LVEF ≥ 35% or asymptomatic left ventricular dysfunction.
✕. Patients with NYHA class IV CHF.
✕. Patients with history of ventricular arrhythmias causing pre-syncope or syncope, cardiac arrest or a spontaneous episode of sustained ventricular tachycardia (VT) (≥30 seconds at rates of \>100 bpm), unless these occurred within 48 hours of a myocardial infarction.
✕. Females who are pregnant or have childbearing potential and are not using reliable methods of contraception.
✕. Patients with history of restrictive, infiltrative, or hypertrophic cardiomyopathy; arrhythmogenic cardiomyopathy; constrictive pericarditis; congenital heart disease; surgically correctable valvular disease; and/or inoperable obstructive valvular disease.