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CompletedNCT00305240Updated Feb 13, 2008

MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients

An interventional study of T Wave Alternans Test in Myocardial Infarction, Arrhythmia, Ventricular and Ischemic Cardiomyopathy, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 47 sites in United States. Per ClinicalTrials.gov, last updated 2008-02-13.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
656
Allocation
Non-randomized
Sex
All
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Study 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 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.

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Conditions studied

  • Myocardial Infarction
  • Arrhythmia, Ventricular
  • Ischemic Cardiomyopathy

Keywords

  • Myocardial Infarction
  • Microvolt T Wave Alternans Test
  • Implantable Cardioverter Defibrillator (ICD)
  • Ventricular Arrythmias
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 656 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients indicated for an ICD with a history of heart attacks
  • LVEF \<= 0.30 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patients with prior ICD
  • Patients unable to complete follow-up visits at the study center
  • Patients who are enrolled or intend to participate in another clinical study that would compete with the study objectives (assessment will be the responsibility of the Clinical Trial Leader with guidance from the Executive Committee)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
656 participants

Interventions

  • ProcedureT Wave Alternans Test
06

What researchers measure

Primary outcomes

  1. Demonstrate that the life-threatening ventricular tachyarrhythmic event-free survival probability is greater in patients with a baseline MTWA Negative result as compared to patients with a baseline MTWA Non-Negative (Positive or Indeterminate) result.

Secondary outcomes

  1. Compare occurrence of all ventricular events between both groups

  2. Identify predictors of life threatening ventricular arrhythmias

  3. Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results

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Study locations

47 sites
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Walnut Creek, California, United States
  • Denver, Colorado, United States
  • Hartford, Connecticut, United States
  • Hollywood, Florida, United States
  • Naples, Florida, United States
  • Safety Harbor, Florida, United States
  • Atlanta, Georgia, United States
  • Joliet, Illinois, United States
  • Springfield, Illinois, United States
  • Beech Grove, Indiana, United States
  • Kansas City, Kansas, United States
  • New Orleans, Louisiana, United States
  • Hyannis, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • Saginaw, Michigan, United States
  • St. Joseph, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • East Islip, New York, United States
  • Flushing, New York, United States
  • West Islip, New York, United States
  • Gastonia, North Carolina, United States
  • Greensboro, North Carolina, United States
  • High Point, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Toledo, Ohio, United States
  • Doylestown, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Scranton, Pennsylvania, United States
  • Spartanburg, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Germantown, Tennessee, United States
  • Amarillo, Texas, United States
  • Corpus Christi, Texas, United States
  • Plano, Texas, United States
  • Tyler, Texas, United States
  • Burlington, Vermont, United States
  • Chesapeake, Virginia, United States
  • Portsmouth, Virginia, United States
  • Appleton, Wisconsin, United States
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References and documents

Publications

  • Chow T, Kereiakes DJ, Onufer J, Woelfel A, Gursoy S, Peterson BJ, Brown ML, Pu W, Benditt DG; MASTER Trial Investigators. Does microvolt T-wave alternans testing predict ventricular tachyarrhythmias in patients with ischemic cardiomyopathy and prophylactic defibrillators? The MASTER (Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients) trial. J Am Coll Cardiol. 2008 Nov 11;52(20):1607-15. doi: 10.1016/j.jacc.2008.08.018. PubMed 18992649 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00305240
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
First posted
Mar 21, 2006
Start date
Oct 2003
Primary completion
Feb 2007
Completion
Feb 2007
Last update
Feb 13, 2008

Study contacts

David G. Benditt, MD
study chair · University of Minnesota
Theodore Chow, MD
study chair · The Lindner Center for Research and Education
Dean J Kereiakes, MD, FACC
study chair · The Lindner Center for Research and Education
View the source record on ClinicalTrials.gov ↗

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