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MADIT S-ICD


Title Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator
Therapeutic Area Myocardial Heart Disease
Principal Investigator Christopher Madias, MD
Min Age 65 Years
Gender Any
Contact Melaine Marshall, RN
617-636-5938
More Information https://clinicaltrials.gov/ct2/show/NCT02787785

Overview

The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.

Study Details

Inclusion Criteria

  • Prior Myocardial Infarction
  • Presence of Diabetes Mellitus for greater than 3 months
  • Ejection Fraction between 36-50%

Exclusion Criteria

  • Under age of 65
  • Ejection fraction outside range of 36-50%
  • No prior myocardial infarction

Study Requirements

In this study, subjects will be randomized to receive a subcutaneous implantable cardioverter defribillator or Conventional Medical Therapy (CMT). Randomization will be stratified by enrolling site, in 2:1 (S-ICD:CMT) scheme. Length of follow up for each subject will be dependent on the date of entry into this study, since all subjects will be followed to a common study termination date.