The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events

Tachycardia, Ventricular Clinical Trial

— VITAL  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00510731
• Other study ID #: VTI-2003-03
• Status: Withdrawn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

Related Conditions & MeSH terms

• Cardiac Sudden Death
• Death
• Death, Sudden
• Death, Sudden, Cardiac
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

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,