Study Stopped
Lack of funding
The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events
VITAL
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
1 other identifier
observational
N/A
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2006
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 1, 2007
CompletedFirst Posted
Study publicly available on registry
August 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 9, 2015
December 1, 2015
3.1 years
August 1, 2007
December 7, 2015
Conditions
Keywords
Eligibility Criteria
Patients at high risk of arrhythmic event who do not have an ICD
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
VA GLAHS - David Geffen School of Medicine at UCLA
Los Angeles, California, 90073, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Cardiovascular Consultants Medical Group
San Ramon, California, 94583, United States
Cardiovascular Consultants Medical Group
Walnut Creek, California, 94598, United States
St Francis Hospital and Medical Center, Hoffman Heart Institute
Hartford, Connecticut, 06105, United States
Jim Moran Heart & Vascular Center
Fort Lauderdale, Florida, 33308, United States
Florida Institute for Cardiovascular Care
Hollywood, Florida, 33021, United States
Cardiac Disease Specialists
Atlanta, Georgia, 30309, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
VA Boston Healthcare System
West Roxbury, Massachusetts, 02132, United States
Michigan Heart, PC
Ypsilanti, Michigan, 48197, United States
Mid America Heart Institute / Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Michael's Medical Center
Newark, New Jersey, 07102, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
Heart Institute of the Cascades
Bend, Oregon, 97701, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Reynolds, MD
VA Boston Healthcare System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2007
First Posted
August 2, 2007
Study Start
November 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 9, 2015
Record last verified: 2015-12