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| Sponsor: | Medtronic Cardiac Rhythm Disease Management |
|---|---|
| Collaborator: |
Medtronic |
| Information provided by: | Medtronic Cardiac Rhythm Disease Management |
| ClinicalTrials.gov Identifier: | NCT00305240 |
Purpose
The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. MTWA testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The objective of the study is to prove that if a patient has a negative MTWA test, they will be less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. The results of the study will help doctors to determine which patients would benefit the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction Arrhythmia, Ventricular Ischemic Cardiomyopathy |
Procedure: T Wave Alternans Test |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients (MASTER I) |
| Estimated Enrollment: | 656 |
| Study Start Date: | October 2003 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Walnut Creek, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Hartford, Connecticut, United States | |
| United States, Florida | |
| Safety Harbor, Florida, United States | |
| Hollywood, Florida, United States | |
| Naples, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Springfield, Illinois, United States | |
| Joliet, Illinois, United States | |
| United States, Indiana | |
| Beech Grove, Indiana, United States | |
| United States, Kansas | |
| Kansas City, Kansas, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Massachusetts | |
| Hyannis, Massachusetts, United States | |
| United States, Michigan | |
| Saginaw, Michigan, United States | |
| Grand Rapids, Michigan, United States | |
| St. Joseph, Michigan, United States | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, Nevada | |
| Las Vegas, Nevada, United States | |
| United States, New York | |
| Flushing, New York, United States | |
| West Islip, New York, United States | |
| East Islip, New York, United States | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States | |
| Greensboro, North Carolina, United States | |
| Gastonia, North Carolina, United States | |
| High Point, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| Cleveland, Ohio, United States | |
| Columbus, Ohio, United States | |
| Toledo, Ohio, United States | |
| United States, Pennsylvania | |
| Scranton, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| Doylestown, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| Spartanburg, South Carolina, United States | |
| United States, Tennessee | |
| Chattanooga, Tennessee, United States | |
| Germantown, Tennessee, United States | |
| United States, Texas | |
| Corpus Christi, Texas, United States | |
| Tyler, Texas, United States | |
| Plano, Texas, United States | |
| Amarillo, Texas, United States | |
| United States, Vermont | |
| Burlington, Vermont, United States | |
| United States, Virginia | |
| Chesapeake, Virginia, United States | |
| Portsmouth, Virginia, United States | |
| United States, Wisconsin | |
| Appleton, Wisconsin, United States | |
| Study Chair: | David G. Benditt, MD | University of Minnesota |
| Study Chair: | Theodore Chow, MD | The Lindner Center for Research and Education |
| Study Chair: | Dean J Kereiakes, MD, FACC | The Lindner Center for Research and Education |
More Information
| Responsible Party: | Medtronic CRDM Core Clinical ( Brett Peterson / Sr. Clinical Trial Leader ) |
| Study ID Numbers: | 220a |
| Study First Received: | March 20, 2006 |
| Last Updated: | February 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00305240 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Myocardial Infarction Microvolt T Wave Alternans Test Implantable Cardioverter Defibrillator (ICD) Ventricular Arrythmias |
|
Necrosis Pathologic Processes Heart Diseases Myocardial Ischemia Vascular Diseases Cardiovascular Diseases |
Ischemia Infarction Cardiomyopathies Myocardial Infarction Arrhythmias, Cardiac |