Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187291
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2005-09-13
Brief Title:
Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms ABCD Study
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Alternans Before Cardioverter Defibrillator ABCD Trial
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ABCD clinical study is designed to determine if a T-Wave Alternans TWA test is equivalent to an Electrophysiology Study EPS in predicting life-threatening heart rhythms in patients with ischemic heart disease left ventricular dysfunction and non-sustained tachycardia Patients undergo both the TWA test and EP study and receive an Implantable Cardioverter Defibrillator ICDif either of the tests show the patient is at risk The patient is then followed for 2 years The incidence of a ventricular tachyarrhythmia events and total mortality are to be evaluated over the duration of the study
Detailed Description:
The primary objective of this study is to test the hypothesis that therapy directed primarily by a T wave alternans TWA test measured non-invasively during exercise is equivalent to therapy directed by an electrophysiological study EPS in predicting spontaneous ventricular tachyarrhythmic events VTEs in patients with ischemic heart disease left ventricular dysfunction and asymptomatic non-sustained ventricular tachycardia NSVT
In the absence of any previous life-threatening ventricular arrhythmia ie for primary prevention ICD implantation is currently indicated in patients with ischemic heart disease left ventricular dysfunction asymptomatic non-sustained ventricular tachycardia and a positive EPS The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death SCD in patients with ischemic heart disease left ventricular dysfunction and asymptomatic non-sustained ventricular tachycardia
This is a prospective multi-center study to demonstrate the following
PRIMARY HYPOTHESIS a TWA test directed therapy is equivalent to EPS directed therapy in predicting VTEs in patients with ischemic heart disease LVEF less than 040 and asymptomatic non-sustained ventricular tachycardia The study will determine whether the positive predictive value of TWA test directed therapy is equivalent to the positive predictive value of EPS directed therapy The study will also determine whether the negative predictive value of TWA test directed therapy is equivalent to the negative predictive value of EPS directed therapy The positive groups under TWA test directed therapy will be compared with the positive groups under EPS directed therapy and the negative groups under TWA directed therapy will be compared with the negative groups under EPS directed therapy SECONDARY HYPOTHESIS The study will determine whether the positive predictive value of a TWA test not including indeterminates is equivalent to the positive predictive value of an EPS in predicting future VTEs The study will also determine whether the negative predictive value of a TWA test not including indeterminates is equivalent to the negative predictive value of an EPS in predicting future VTEs The TWA test positive groups will be compared with the EPS positive groups and the TWA test negative groups will be compared with the EPS negative groups The secondary hypothesis will also be tested against the primary endpoint defined above
In the absence of any previous life-threatening ventricular arrhythmia ie for primary prevention ICD implantation is currently indicated in patients with ischemic heart disease left ventricular dysfunction asymptomatic non-sustained ventricular tachycardia and a positive EPS The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death SCD in patients with ischemic heart disease left ventricular dysfunction and asymptomatic non-sustained ventricular tachycardia
This is a prospective multi-center study to demonstrate the following
PRIMARY HYPOTHESIS a TWA test directed therapy is equivalent to EPS directed therapy in predicting VTEs in patients with ischemic heart disease LVEF less than 040 and asymptomatic non-sustained ventricular tachycardia The study will determine whether the positive predictive value of TWA test directed therapy is equivalent to the positive predictive value of EPS directed therapy The study will also determine whether the negative predictive value of TWA test directed therapy is equivalent to the negative predictive value of EPS directed therapy The positive groups under TWA test directed therapy will be compared with the positive groups under EPS directed therapy and the negative groups under TWA directed therapy will be compared with the negative groups under EPS directed therapy SECONDARY HYPOTHESIS The study will determine whether the positive predictive value of a TWA test not including indeterminates is equivalent to the positive predictive value of an EPS in predicting future VTEs The study will also determine whether the negative predictive value of a TWA test not including indeterminates is equivalent to the negative predictive value of an EPS in predicting future VTEs The TWA test positive groups will be compared with the EPS positive groups and the TWA test negative groups will be compared with the EPS negative groups The secondary hypothesis will also be tested against the primary endpoint defined above
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