Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

Not Applicable

Completed

Conditions: Tachycardia
Cardiovascular Disease
Diabetes Mellitus

Registration Number: NCT02787785

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age ≥ 65 years on date of consent
Diabetes mellitus treated with oral hypoglycemic agents, non-insulin injectable and/or insulin for the past 3 calendar months or longer prior to consent date
LV ejection fraction (LVEF) of 36-50% documented by imaging (preferably by MRI or echocardiographic methods), within 12 calendar months before consent date and at least 3 calendar months after most recent Myocardial Infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
One or more clinically documented, enzyme-positive myocardial infarctions, more than 3 calendar months prior to consent date*. (If enzyme information and clinical documentation is not available, there must be a clear evidence of prior silent myocardial infarction identified as either new pathologic Q waves on ECG or imaging documentation of an infarcted area (left ventricular angiography/ nuclear scan/ MRI) Note: MI qualification based on the Universal Definition of MI)
Qualifying 12-lead ECG within 6 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG. (The qualifying ECG* can be sinus rhythm or atrial fibrillation (patients with persistent or permanent atrial fibrillation should have a controlled ventricular response <100 bpm on consent date) *QRS duration on the qualifying ECG >90 msec)
Passing S-ICD Screening ECG performed per applicable user's manual on or after the consent date that identifies one or more qualifying S-ICD sensing vectors

Exclusion Criteria

Ejection fraction >50% or <36% within 12 calendar months prior to consent date and at least 3 calendar months after the most recent MI, PCI or CABG
Existing guideline based indication for an implantable cardioverter defibrillator (ICD), pacemaker, cardiac resynchronization therapy device (CRT), or cardiac resynchronization therapy device with defibrillator (CRT-D) therapy
Existing or previously implanted ICD, CRT, CRT-D, or pacemaker device system
Active infection at the time of consent
Contraindication for S-ICD implantation according to the S-ICD pulse generator (PG) User's Manual
Hemodialysis and/or peritoneal dialysis at the time of enrollment
New York Heart Association Class IV in the past 3 calendar months prior to or at the time of consent date
Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to the consent date
Enzyme-positive myocardial infarction or silent myocardial infarction diagnosed within 3 calendar months prior to the consent date
Unstable angina with need for outpatient treatment or hospitalization (change/addition of anti-anginal medication and/or coronary revascularization), within 3 calendar months prior to the consent date
Angiographic evidence of coronary disease in a patient that is a candidate for coronary revascularization and is likely to undergo CABG or PCI in the next 3 calendar months
High risk for arterial embolism (e.g. presence of mobile left ventricular thrombus)
Hemodynamically significant congenital heart disease, aortic valvular heart disease, or amyloid heart disease
Baseline body mass index > 45 kg/m2
On a heart transplant list or likely to undergo heart transplant within one calendar year
Presence of any other disease, other than the subject's cardiac disease, that in the opinion of the investigator is likely to significantly reduce the patient's likelihood of survival for the duration of the trial (e.g. cancer, liver failure).
Unwillingness or inability to cooperate with the protocol
Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
Reversible causes of heart disease (e.g. viral myocarditis or tachycardia induced cardiomyopathy)
Participation in other clinical trials (observational registries are allowed with approval from the CDC)
Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
Unwillingness to sign the consent for participation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.	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.

Secondary Outcome Measures

Name	Time	Method
Sudden Death	Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.	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.
All-Cause Mortality in Various Subgroups	Outcome measured timeframe includes all available follow-up. Median 61 (4, 71) months.	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.

Trial Locations

Locations (49): 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
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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Heart Center Research, LLC.
🇺🇸Huntsville, Alabama, United States