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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01378572
Other study ID # SDMC060911
Secondary ID
Status Recruiting
Phase N/A
First received June 21, 2011
Last updated June 21, 2011
Start date November 2009

Study information

Verified date June 2011
Source Catholic University of the Sacred Heart
Contact Pasquale Santangeli, MD
Phone 5127014689
Email pasquale.santangeli@gmail.com
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.


Description:

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Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Centro Cardiologico Monzino Milan
Italy Policlinico "A. Gemelli" Rome
United States Texas Cardiac Arrhythmia Institute, St. David's Medical Center Austin Texas

Sponsors (5)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Milan, Italy, Dell'Angelo Hospital, Mestre-Venice, Italy, Policlinico Casilino ASL RMB, Rome, Italy, Texas Cardiac Arrhythmia Research Foundation

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arrhythmic Event ICD shock on rapid sustained ventricular tachycardia or ventricular fibrillation or effective antitachycardia pacing. 2 years No
Primary Change in Arrhythmogenic Substrate Change in the arrhythmogenic substrate in patients who will experience an arrhythmic event compared to a matched control group who will remain free from arrhythmic event. 2 years No
Secondary Heart failure events Hospitalization for heart failure events 2 years No
Secondary Death All-cause mortality 2 years No
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