DEFINITE: Defibrillator in Non-Ischemic Cardiomyopathy Treatment Evaluation Trial

ICD therapy to optimal medical therapy reduces all-cause mortality in non-ischemic cardiomyopathy patients with low ejection fraction and
NSVT/PVC's compared to optimal medical therapy only. The enrolled patients in this trial had a diagnosis of nonischemic dilated
cardiomyopathy, a LVEF < 36%, and PVC's or unsustained ventricular tachycardia. The control group received standard medical therapy, while the test-ICD group received standard medical therapy and a single-chamber ICD. At 2 years, the mortality rate was greater in the control group (14.1%) than the test-ICD group (7.9%). There were significantly more sudden deaths from arrhythmia in the control group than there were in the test-ICD group (p=0,006). The investigators concluded that the combination of ICD therapy with standard optimal medical therapy reduced the risk of sudden death from arrhythmia in patients with severe non-ischemic dilated cardiomyopathy.
The Holter ECG recordings acquired in this trial are now hosted in the THEW and are available for research. Two hundred and thirty six patients were enrolled in this study and got an Holter ECG recording acquired either at enrollment of later during the trial, the patients were followed for 29 months in average. The enrollment criteria included LVEF<36%, the presence of ambient arrhythmias, a history of symptomatic heart failure, and the presence of non-ischemic dilated cardiomyopathy. Ambient arrhythmias were defined by an episode of non-sustained ventricular tachycardia on Holter (3 to 15 beats at heart rate superior to 120 beats per minutes) (different from the ECGs hosted in the THEW database). The acquisition of the Holter recordings was initiated after the start of the trial. ECGs were acquired at baseline or at the next scheduled follow-up visit for patients who were already enrolled in the study.
Importantly, the THEW designed a specific type of research agreement with Northwestern University (Chicago, IL) in order to enable the
distribution of the DEFINITE data to the Scientific community. This agreement includes the involvement of a special committee to review the research proposal proposed by THEW members. This committee consists of Prof. Alan Kadish, his collaborators and members of the THEW steering committee. This ad-hoc group will be appointed according to the topics of the research proposal submitted by the THEW members.

Study Design:

•Inclusion Criteria:
Non-ischemic dilated cardiomyopathy; spontaneous PVCs (> 10/hour) or NSVT; LVEF <35%.

Exclusion Criteria:
Symptomatic ventricular arrhythmia or history of sudden cardiac death; NYHA class IV heart failure

Database Characteristics:
Number of patients included in the database: 301

Number of recordings included in the database: 401

Distribution of Holter recordings per patient per time of visit:

One of the Holter recording did not have information about the time of the visit. We opted to keep this recording in the database and add it to the unscheduled time visit. Unsch: ECG holter recorded during unsheduled patient visit

Basic clinical infromation on the population :

To be released soon

ECG Number of Leads: 3 orthogonal lead configuration

ECG Sampling Frequency : 500 Hz and 1000Hz, provided in the ECG ISHNE file header for each patients

ECG Amplitude Resolution: provided in the ECG ISHNE file header for each patients

Clinical Information: This database includes many clinical factors and the study endpoints. A complete list of the recorded factors is provided in a pdf file (click here to download). Importantly, the non-HIPAA compliant infromation described in this document have been excluded from the clinical dataset.