Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510731
Status:
WITHDRAWN
Last Update Posted:
2015-12-09
First Post:
2007-08-01
Brief Title:
The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events
Sponsor:
Vicor Technologies Inc
Organization:
Vicor Technologies Inc
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAL
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 450000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None