Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00510731
Study type Observational
Source Vicor Technologies, Inc.
Contact
Status Withdrawn
Phase N/A
Start date November 2006
Completion date December 2009

See also
  Status Clinical Trial Phase
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT04070300 - Physical Activity and Ventricular Arrhythmias N/A
Completed NCT04075253 - Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia N/A
Completed NCT00000531 - Antiarrhythmics Versus Implantable Defibrillators (AVID) Phase 3
Completed NCT00000480 - Multicenter Unsustained Tachycardia Trial (MUSTT) Phase 3
Completed NCT05086510 - Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping N/A
Completed NCT01940081 - The Leiden Nonischemic Cardiomyopathy Study
Recruiting NCT01222156 - Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping Phase 1/Phase 2
Terminated NCT00749671 - Bispectral Index Monitoring During Testing in the Electrophysiology Lab N/A
Recruiting NCT00385749 - Right Ventricular Defibrillation Lead Select Site Study N/A
Completed NCT00382928 - Automatic External Defibrillation Monitoring in Cardiac Arrest Phase 1
Completed NCT00279279 - PREPARE - Primary Prevention Parameters Evaluation N/A
Terminated NCT00776087 - European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco) N/A
Completed NCT01572246 - Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators N/A
Completed NCT00170287 - SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD) Phase 4
Completed NCT00147277 - ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy Phase 4
Completed NCT00004559 - Fatty Acid Antiarrhythmia Trial (FAAT) Phase 3
Completed NCT00702117 - Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias Phase 4
Completed NCT00232297 - Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS Phase 2
Active, not recruiting NCT01639365 - SmartTouch Catheter in Ablation of Ventricular Tachycardia N/A