Clinical Trials Logo

Clinical Trial 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 (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.


Clinical Trial 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 (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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00187291
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase Phase 3
Start date April 2001
Completion date July 2006

See also
  Status Clinical Trial Phase
Terminated NCT04066738 - Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Enrolling by invitation NCT02930265 - Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy N/A
Completed NCT01215253 - Ranolazine Implantable Cardioverter-Defibrillator Trial Phase 3
Completed NCT04508608 - Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
Recruiting NCT05888662 - Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT) N/A
Completed NCT03857906 - Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery
Completed NCT02501811 - Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure Phase 2
Recruiting NCT02058771 - Utilising Lifemap to Investigate Malignant Arrhythmia Therapy
Not yet recruiting NCT01946048 - Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy Phase 1
Terminated NCT01759212 - Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure. Phase 2/Phase 3
Not yet recruiting NCT01447069 - Use of Beta-agonists in Stable Severe Congestive Heart Failure N/A
Recruiting NCT00972114 - CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy Phase 1/Phase 2
Completed NCT00896142 - Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation) N/A
Recruiting NCT01076660 - Left Ventricular Structural Predictors of Sudden Cardiac Death
Completed NCT00305240 - MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients N/A
Completed NCT00305214 - MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients N/A
Active, not recruiting NCT00962364 - Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
Recruiting NCT05769036 - Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients N/A
Completed NCT03862339 - The SoundScar Study The SOUNDSCAR Study