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| Sponsor: | St. Jude Medical |
|---|---|
| Collaborators: |
Cambridge Heart Inc. MetroHealth Medical Center |
| Information provided by: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00187291 |
Purpose
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 (ICD)if 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Cardiomyopathy LV Dysfunction |
Procedure: T-Wave Alternans test |
Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study |
| Official Title: | Alternans Before Cardioverter Defibrillator (ABCD) Trial |
| Estimated Enrollment: | 618 |
| Study Start Date: | April 2001 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
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 (i.e., 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 0.40, 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following inclusion criteria may be enrolled in the study:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria will not be eligible for enrollment:
Contacts and Locations| Study Chair: | David Rosenbaum, MD | MetroHealth Medical Center |
| Study Chair: | Otto Costantini, MD | MetroHealth Medical Center |
More Information
| Responsible Party: | MetroHealth Medical Center ( David Rosenbaum, MD ) |
| Study ID Numbers: | G010050 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00187291 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
T-Wave Alternans ICD Primary Prevention |
|
Heart Diseases Cardiovascular Diseases Cardiomyopathies |