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

April 15, 2024 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12683
        • Unfallkrankenhaus Berlin
      • Hamburg, Germany, 20246
        • Universitaetsklinik Eppendorf
    • Niedersachsen
      • Hannöver, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
  • Israel
      • Jerusalem, Israel
        • Hadassah Hebrew University Medical Center
      • Rechovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria
    • Niguarda
      • Milano, Niguarda, Italy, 20162
        • Azienda Ospedaliera Ospedale Niguarda CA Granda
  • Netherlands
    • CX
      • Utrecht, CX, Netherlands, 3584
        • UMC Utrecht
    • NH
      • Amsterdam, NH, Netherlands, 1105AZ
        • Academisch Medisch Centrum
  • Spain
    • Aragon
      • Zaragosa, Aragon, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • University of Navarra, Department of Cardiology
  • Switzerland
      • Zürich, Switzerland
        • University Hospital Zurich
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC.
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic- Scottsdale
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernard's Medical Center
    • California
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedar-Sinai Medical Center
      • Oakland, California, United States, 94609
        • Alta Bates Summit Hospital
      • Pasadena, California, United States, 91105
        • Huntington Hospital
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Healthcare
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Advanced Cardiovascular Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates of Delaware Valley
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • Rochester, New York, United States, 14642
        • Strong Memorial / University of Rochester Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Heart and Vascular
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
      • Columbus, Ohio, United States, 43210
        • Ohio State Wexner Medical Center
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19008
        • Abington Memorial Hospital
      • Phoenixville, Pennsylvania, United States, 19460
        • Phoenixville Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center - Presbyterian
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, Houston
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional Medical Therapy
This arm of the trial continues with their current conventional medical therapy.
Active Comparator: Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial receives a subcutaneous implantable defibrillator.
Device: Subcutaneous Implantable Cardioverter Defibrillator
The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: Through study completion,estimated average of 2.6 years follow-up
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.
Through study completion,estimated average of 2.6 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality in various subgroups
Time Frame: Through study completion,estimated average of 2.6 years follow-up
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.
Through study completion,estimated average of 2.6 years follow-up
Sudden Death in various subgroups
Time Frame: Through study completion,estimated average of 2.6 years follow-up
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.
Through study completion,estimated average of 2.6 years follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
S-ICD Inappropriate shock frequency
Time Frame: Through study completion,estimated average of 2.6 years follow-up
Pre-specific tertiary statistical analyses will be descriptive and exploratory
Through study completion,estimated average of 2.6 years follow-up
S-ICD Inappropriate shock outcomes
Time Frame: Through study completion,estimated average of 2.6 years follow-up
Pre-specific tertiary statistical analyses will be descriptive and exploratory
Through study completion,estimated average of 2.6 years follow-up
S-ICD treated ventricular arrhythmia frequency
Time Frame: Through study completion,estimated average of 2.6 years follow-up
Pre-specific tertiary statistical analyses will be descriptive and exploratory
Through study completion,estimated average of 2.6 years follow-up
S-ICD treated ventricular arrhythmia outcomes
Time Frame: Through study completion,estimated average of 2.6 years follow-up
Pre-specific tertiary statistical analyses will be descriptive and exploratory
Through study completion,estimated average of 2.6 years follow-up
S-ICD device complications
Time Frame: Through study completion, estimated average of 2.6 years follow-up
Pre-specific tertiary statistical analyses will be descriptive and exploratory
Through study completion, estimated average of 2.6 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

University of Rochester

Investigators

  • Principal Investigator: Valentina Kutyifa, MD, MSc, PhD, University of Rochester Heart Research Follow-up Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2017

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimated)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADIT S-ICD (C1834)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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