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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Vicor Technologies, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vicor Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00510731
First received: August 1, 2007
Last updated: April 8, 2009
Last verified: April 2009
  Purpose

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.


Condition
Tachycardia, Ventricular
Cardiac Sudden Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Vicor Technologies, Inc.:

Estimated Enrollment: 900
Study Start Date: November 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients at high risk of arrhythmic event who do not have an ICD

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510731

Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
VA GLAHS - David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90073
Cardiovascular Consultants Medical Group
San Ramon, California, United States, 94583
Cardiovascular Consultants Medical Group
Walnut Creek, California, United States, 94598
United States, Connecticut
St Francis Hospital and Medical Center, Hoffman Heart Institute
Hartford, Connecticut, United States, 06105
United States, Florida
Jim Moran Heart & Vascular Center
Ft Lauderdale, Florida, United States, 33308
Florida Institute for Cardiovascular Care
Hollywood, Florida, United States, 33021
United States, Georgia
Cardiac Disease Specialists
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
VA Boston Healthcare System
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
Michigan Heart, PC
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Mid America Heart Institute / Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, Ohio
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
United States, Oregon
Heart Institute of the Cascades
Bend, Oregon, United States, 97701
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Vicor Technologies, Inc.
Investigators
Principal Investigator: Matthew Reynolds, MD VA Boston Healthcare System
  More Information

No publications provided

Responsible Party: David Fater, Chief Executive Officer, Vicor Technologies
ClinicalTrials.gov Identifier: NCT00510731     History of Changes
Other Study ID Numbers: VTI-2003-03
Study First Received: August 1, 2007
Last Updated: April 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Vicor Technologies, Inc.:
Ventricular Tachycardia
Cardiac Sudden Death
Ventricular Fibrillation
Heart Rate Variability

Additional relevant MeSH terms:
Death
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Arrest

ClinicalTrials.gov processed this record on October 16, 2014