Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
- Conditions
- TachycardiaCardiovascular DiseaseDiabetes Mellitus
- Interventions
- Device: Subcutaneous Implantable Cardioverter Defibrillator
- 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
- 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
- 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
- Arm && Interventions
Group Intervention Description Subcutaneous Implantable Cardioverter Defibrillator Subcutaneous Implantable Cardioverter Defibrillator This arm of the trial receives a subcutaneous implantable defibrillator.
- 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)
Cardiovascular Associates of Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
University of Washington
🇺🇸Seattle, Washington, United States
Heart Center Research, LLC.
🇺🇸Huntsville, Alabama, 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
Huntington Hospital
🇺🇸Pasadena, California, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Alta Bates Summit Hospital
🇺🇸Oakland, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Northwell Health
🇺🇸Manhasset, New York, United States
North Carolina Heart and Vascular
🇺🇸Raleigh, North Carolina, United States
Strong Memorial / University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Ohio State Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center - Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Phoenixville Hospital
🇺🇸Phoenixville, Pennsylvania, United States
Promedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
University of Texas, Houston
🇺🇸Houston, Texas, United States
Sentara Norfolk General
🇺🇸Norfolk, Virginia, United States
Medizinische Hochschule Hannover
🇩🇪Hannöver, Niedersachsen, Germany
PeaceHealth Southwest Medical Center
🇺🇸Vancouver, Washington, United States
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Universitaetsklinik Eppendorf
🇩🇪Hamburg, Germany
Azienda Ospedaliera Ospedale Niguarda CA Granda
🇮🇹Milano, Niguarda, Italy
Azienda Ospedaliera Universitaria
🇮🇹Verona, Italy
Hospital Universitario Miguel Servet
🇪🇸Zaragosa, Aragon, Spain
University of Navarra, Department of Cardiology
🇪🇸Pamplona, Navarra, Spain
Advanced Cardiovascular Specialists
🇺🇸Shreveport, Louisiana, United States
Hadassah Hebrew University Medical Center
🇮🇱Jerusalem, Israel
Kaplan Medical Center
🇮🇱Rechovot, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
University Hospital Zurich
🇨🇭Zürich, Switzerland
Academisch Medisch Centrum
🇳🇱Amsterdam, NH, Netherlands
St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Mayo Clinic- Scottsdale
🇺🇸Scottsdale, Arizona, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
UMC Utrecht
🇳🇱Utrecht, CX, Netherlands
University of Louisville
🇺🇸Louisville, Kentucky, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States