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Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)

Primary Purpose

Ischemic Cardiomyopathy, LV Dysfunction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
T-Wave Alternans test
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Cardiomyopathy focused on measuring T-Wave Alternans, ICD, Primary Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment. Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy inclusion criteria for the trial. The patient is 18 years of age or older. In the judgement of the principal investigator, the patient is capable of undergoing a sub-maximal treadmill exercise test to a heart rate of 120 bpm. The patient has signed the latest IRB approved informed consent form. Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment: The patient is unable to give informed consent. The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication). The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial. The patient has unstable coronary artery disease. The patient has contraindications to ICD implantation. A submaximal exercise test is contraindicated. The patient has persistent atrial fibrillation or flutter. The patient is less than 28 days post MI, post CABG, or post coronary angioplasty. The patient has an LVEF 0.40, but no evidence of ischemic heart disease as defined by section 4.1. The patient has NYHA functional Class IV congestive heart failure symptoms at the time of enrollment. The patient is on any class 1 or 3 antiarrhythmic drug. The patient is participating in a study of another investigational device or drug. If, in the opinion of the investigator, this would not interfere with this study, the eligibility of such a patient should be discussed with the primary investigators of the ABCD trial, Drs. Rosenbaum or Costantini. The patient has any other significant medical condition or acute illness that in the opinion of the investigator precludes participation. The patient has a previous history of syncope, unless the episode was clearly not caused by a ventricular tachyarrhythmia. The patient has a life expectancy of less than one year from any cause. The patient has a positive pregnancy test. The patient is not geographically stable or is unable to comply with the follow up schedule.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ventricular tachyarrhythmic events

    Secondary Outcome Measures

    Total Mortality
    Ventricular tachyarrhythmic events below rate detection of the ICD

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    July 11, 2023
    Sponsor
    Abbott Medical Devices
    Collaborators
    Cambridge Heart Inc., MetroHealth Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00187291
    Brief Title
    Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)
    Official Title
    Alternans Before Cardioverter Defibrillator (ABCD) Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott Medical Devices
    Collaborators
    Cambridge Heart Inc., MetroHealth Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 (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.
    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 (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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Cardiomyopathy, LV Dysfunction
    Keywords
    T-Wave Alternans, ICD, Primary Prevention

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    618 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    T-Wave Alternans test
    Primary Outcome Measure Information:
    Title
    Ventricular tachyarrhythmic events
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Total Mortality
    Time Frame
    12 months
    Title
    Ventricular tachyarrhythmic events below rate detection of the ICD
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment. Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy inclusion criteria for the trial. The patient is 18 years of age or older. In the judgement of the principal investigator, the patient is capable of undergoing a sub-maximal treadmill exercise test to a heart rate of 120 bpm. The patient has signed the latest IRB approved informed consent form. Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment: The patient is unable to give informed consent. The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication). The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial. The patient has unstable coronary artery disease. The patient has contraindications to ICD implantation. A submaximal exercise test is contraindicated. The patient has persistent atrial fibrillation or flutter. The patient is less than 28 days post MI, post CABG, or post coronary angioplasty. The patient has an LVEF 0.40, but no evidence of ischemic heart disease as defined by section 4.1. The patient has NYHA functional Class IV congestive heart failure symptoms at the time of enrollment. The patient is on any class 1 or 3 antiarrhythmic drug. The patient is participating in a study of another investigational device or drug. If, in the opinion of the investigator, this would not interfere with this study, the eligibility of such a patient should be discussed with the primary investigators of the ABCD trial, Drs. Rosenbaum or Costantini. The patient has any other significant medical condition or acute illness that in the opinion of the investigator precludes participation. The patient has a previous history of syncope, unless the episode was clearly not caused by a ventricular tachyarrhythmia. The patient has a life expectancy of less than one year from any cause. The patient has a positive pregnancy test. The patient is not geographically stable or is unable to comply with the follow up schedule.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Rosenbaum, MD
    Organizational Affiliation
    MetroHealth Medical Center
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Otto Costantini, MD
    Organizational Affiliation
    MetroHealth Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19195603
    Citation
    Costantini O, Hohnloser SH, Kirk MM, Lerman BB, Baker JH 2nd, Sethuraman B, Dettmer MM, Rosenbaum DS; ABCD Trial Investigators. The ABCD (Alternans Before Cardioverter Defibrillator) Trial: strategies using T-wave alternans to improve efficiency of sudden cardiac death prevention. J Am Coll Cardiol. 2009 Feb 10;53(6):471-9. doi: 10.1016/j.jacc.2008.08.077.
    Results Reference
    derived

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    Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)

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