MedDataX Logo

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

NCT ID: NCT00510731

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tachycardia, Ventricular Cardiac Sudden Death

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vicor Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA GLAHS - David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Cardiovascular Consultants Medical Group

San Ramon, California, United States

Site Status

Cardiovascular Consultants Medical Group

Walnut Creek, California, United States

Site Status

St Francis Hospital and Medical Center, Hoffman Heart Institute

Hartford, Connecticut, United States

Site Status

Jim Moran Heart & Vascular Center

Fort Lauderdale, Florida, United States

Site Status

Florida Institute for Cardiovascular Care

Hollywood, Florida, United States

Site Status

Cardiac Disease Specialists

Atlanta, Georgia, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

VA Boston Healthcare System

West Roxbury, Massachusetts, United States

Site Status

Michigan Heart, PC

Ypsilanti, Michigan, United States

Site Status

Mid America Heart Institute / Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

St. Michael's Medical Center

Newark, New Jersey, United States

Site Status

Good Samaritan Hospital

Dayton, Ohio, United States

Site Status

Heart Institute of the Cascades

Bend, Oregon, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VTI-2003-03

Identifier Type: -

Identifier Source: org_study_id