Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

Completed · Not applicable

Conditions studied: Tachycardia, Diabetes Mellitus, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT02787785

Run by

Boston Scientific Corporation

People needed

40

Starts

2017-04-17

Expected to finish

2023-06-30

Last updated by the study team

2024-08-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Advanced Cardiovascular Specialists — Shreveport, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Cardiovascular Associates of Delaware Valley — Haddon Heights, New Jersey, United States
• Northwell Health — Manhasset, New York, United States
• Strong Memorial / University of Rochester Medical Center — Rochester, New York, United States
• North Carolina Heart and Vascular — Raleigh, North Carolina, United States
• Ohio State Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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