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Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator | Clinical Trials | Clareo Health

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Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)

NCT02787785•Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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
+12 more criteria

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

Key Dates

Start Date

April 17, 2017

Primary Completion Date

June 30, 2023

Completion Date

June 30, 2023

Last Updated

August 22, 2024

Enrollment

ACTUAL participants

Conditions

TachycardiaDiabetes MellitusCardiovascular Disease

Interventions

Subcutaneous Implantable Cardioverter Defibrillator

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

Inclusion Criteria

Exclusion Criteria

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