This trial is active, not recruiting.

Conditions tachycardia, ventricular, cardiac sudden death
Sponsor Vicor Technologies, Inc.
Start date November 2006
End date December 2009
Trial size 900 participants
Trial identifier NCT00510731, VTI-2003-03


This is a prospective study to evaluating the ability of the PD2i Cardiac Analyzer to predict the risk of serious heart rhythm abnormalities in high-risk patients that do not already have an Implantable Cardioverter Defibrillator.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age >18 years - Left Ventricular Ejection Fraction (LVEF) <35% - Prior myocardial infarction - Symptomatic congestive heart failure - Referred for EP testing and/or prophylactic ICD implantation Exclusion Criteria: - Currently has implanted pacemaker or ICD - Current atrial fibrillation/flutter or atrial fibrillation/flutter requiring cardioversion within the previous 6 months - Cardiac surgery or percutaneous revascularization, MI, unstable angina, or CVA within the previous 30 days - Antiarrhythmic drug therapy other than a beta-blocker within the previous 6 months - Previous episode of sustained VT/VF or cardiac arrest, except in the setting of acute myocardial infarction or other reversible cause - Life expectancy of less than one year from any non-cardiac cause - Expected cardiac transplantation within 6 months

Additional Information

Official title Prospective, Multi-Center Study Of The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of VentrIcular TachyArrhythmic Events Such As, Sudden Cardiac Death, VentricuLar Fibrillation or Ventricular Tachycardia in High Risk Patients
Principal investigator Matthew Reynolds, MD
Description The annual incidence of sudden cardiac death in the United States has recently been estimated at 450,000. Most of these patients die from ventricular tachyarrhythmias. Currently, there is a limited ability to predict reliably which patients are at risk for these events. Implantable cardioverter defibrillators (ICDs) are highly effective at treating the arrhythmias that cause sudden death. Multiple clinical trials demonstrating the efficacy of ICDs for the primary prevention of sudden death have been completed, leading to a relaxation of the selection criteria for their use, and therefore a potentially large expansion in the pool of patients eligible for these devices. This has major economic implications for the health care system, and has led to a need for better prospective identification of patients who are or are not at high risk for sudden death. The existence of beat-to-beat changes in heart rate, termed heart rate variability HRV), has long been recognized by physiologists. However, over the past 15 years, it has been determined that HRV is not a random phenomenon but can be influenced by the brain through the autonomic nervous system. Promising work in the analysis of HRV may provide a means of predicting which patients are at risk for sudden death. HRV analysis utilizes mathematical modeling of ECG data to gain insight into the subtle variations in heartbeat patterns which occur from beat-to-beat. The development of a system that could better identify the patients at risk of arrhythmic events would have a significant impact on clinical and economical fields. This study will test software developed by Vicor Technologies that can potentially identify patients at risk of arrhythmic events. It works as a generic digital-electrocardiogram (ECG) device, as it would normally be used by technical personnel in the routine care of outpatients.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Vicor Technologies, Inc..