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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00510731
Other study ID # VTI-2003-03
Secondary ID
Status Withdrawn
Phase N/A
First received August 1, 2007
Last updated December 7, 2015
Start date November 2006
Est. completion date December 2009

Study information

Verified date December 2015
Source Vicor Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Cardiac Disease Specialists Atlanta Georgia
United States Heart Institute of the Cascades Bend Oregon
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Good Samaritan Hospital Dayton Ohio
United States Jim Moran Heart & Vascular Center Ft Lauderdale Florida
United States St Francis Hospital and Medical Center, Hoffman Heart Institute Hartford Connecticut
United States Florida Institute for Cardiovascular Care Hollywood Florida
United States Mid America Heart Institute / Saint Luke's Hospital Kansas City Missouri
United States UCLA Medical Center Los Angeles California
United States VA GLAHS - David Geffen School of Medicine at UCLA Los Angeles California
United States St. Michael's Medical Center Newark New Jersey
United States Rhode Island Hospital Providence Rhode Island
United States Cardiovascular Consultants Medical Group San Ramon California
United States Washington University School of Medicine St. Louis Missouri
United States Cardiovascular Consultants Medical Group Walnut Creek California
United States VA Boston Healthcare System West Roxbury Massachusetts
United States Michigan Heart, PC Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Vicor Technologies, Inc.

Country where clinical trial is conducted

United States, 

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