Clinical trial NCT00510731: The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tachycardia, Ventricular
Cardiac Sudden Death
Keywords: Ventricular Tachycardia
Cardiac Sudden Death
Ventricular Fibrillation
Heart Rate Variability
Lead sponsor: Vicor Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at high risk of arrhythmic event who do not have an ICD

Brief 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.

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 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

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