The MADIT S-ICD trial was 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. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years.
In this study, subjects were randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization was stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject was dependent on the date of entry into the study, since all subjects were followed to a common study termination date.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
Heart Center Research, LLC.
Huntsville, Alabama, United States
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, United States
Glendale Adventist Medical Center
Glendale, California, United States
University of Southern California
Los Angeles, California, United States
All-Cause Mortality
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
All-Cause Mortality in Various Subgroups
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
Sudden Death
The original study design was event driven with the end date expected to be based on crossing the statistical boundary. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years. The outcomes will be analyzed but are no longer statistically powered for conclusions.
Time frame: Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.
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Cedar-Sinai Medical Center
Los Angeles, California, United States
Alta Bates Summit Hospital
Oakland, California, United States
Huntington Hospital
Pasadena, California, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Emory University
Atlanta, Georgia, United States
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