Status:
COMPLETED
MASTER II - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Myocardial Infarction
Arrhythmia, Ventricular
Eligibility:
All Genders
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients with a history of heart attacks
- LVEF \>0.30 and \<= 0.40 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment.
Exclusion
- Patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (Class I indications)
- Patients who have undergone an electrophysiologic study with ventricular stimulation or a MTWA test within 1 year prior to enrollment
- Patients with medical conditions that preclude the testing required by the Investigational Plan or limit study participation
- Patients unable to complete MTWA testing requirements due to current atrial fibrillation or flutter
- Patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for MTWA testing are not available
- Patients who have experienced an MI within 1 month prior to enrollment
- Patients with advanced cerebrovascular disease per physician's assessment
- Patients classified as NYHA Class IV at time of enrollment
- Patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment
- Patients with a life expectancy of less than 1 year
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00305214
Start Date
October 1 2003
End Date
February 1 2007
Last Update
February 13 2008
Active Locations (47)
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1
Mobile, Alabama, United States
2
Phoenix, Arizona, United States
3
Walnut Creek, California, United States
4
Denver, Colorado, United States