Tachycardia, VentricularVITALNCT00510731
The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events
An observational study of Tachycardia, Ventricular and Cardiac Sudden Death, run by Vicor Technologies, Inc. at 19 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular, Cardiac Sudden Death
- How many people
- 0 participants
- Where
- 19 sitesUnited States
- Study dates
- Nov 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at high risk of arrhythmic event who do not have an ICD
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Cardiac Disease Specialists
Atlanta, Georgia, 30309
Heart Institute of the Cascades
Bend, Oregon, 97701
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29403
Good Samaritan Hospital
Dayton, Ohio, 45406
Jim Moran Heart & Vascular Center
Fort Lauderdale, Florida, 33308
St Francis Hospital and Medical Center, Hoffman Heart Institute
Hartford, Connecticut, 06105
Florida Institute for Cardiovascular Care
Hollywood, Florida, 33021
Mid America Heart Institute / Saint Luke's Hospital
Kansas City, Missouri, 64111
VA GLAHS - David Geffen School of Medicine at UCLA
Los Angeles, California, 90073
UCLA Medical Center
Los Angeles, California, 90095
St. Michael's Medical Center
Newark, New Jersey, 07102
Rhode Island Hospital
Providence, Rhode Island, 02903
Cardiovascular Consultants Medical Group
San Ramon, California, 94583
Washington University School of Medicine
St Louis, Missouri, 63110
Cardiovascular Consultants Medical Group
Walnut Creek, California, 94598
VA Boston Healthcare System
West Roxbury, Massachusetts, 02132
Michigan Heart, PC
Ypsilanti, Michigan, 48197
About this study
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
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.
Read the 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.
- Conditions
- Tachycardia, Ventricular, Cardiac Sudden Death
- Keywords
- Ventricular Tachycardia, Cardiac Sudden Death, Ventricular Fibrillation, Heart Rate Variability
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac, Ventricular Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicor Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Reynolds, MD, Principal investigator, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510731
- Sponsor's protocol ID
- VTI-2003-03
- Acronym
- VITAL
- Status last verified
- Dec 2015
- First submitted
- 1 Aug 2007
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00510731
- Acronym / sponsor ID
- VITAL / VTI-2003-03
- Conditions
- Tachycardia, Ventricular, Cardiac Sudden Death
- Keywords
- Ventricular Tachycardia, Cardiac Sudden Death, Ventricular Fibrillation, Heart Rate Variability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vicor Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at high risk of arrhythmic event who do not have an ICD
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Reynolds, MD principal investigator
VA Boston Healthcare System
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, Ventricular and Cardiac Sudden Death, run by Vicor Technologies, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.