Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

NCT ID: NCT02787785

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2023-06-30

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.

Conditions

Tachycardia; Diabetes Mellitus; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Medical Therapy

This arm of the trial continues with their current conventional medical therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Subcutaneous Implantable Cardioverter Defibrillator

This arm of the trial receives a subcutaneous implantable defibrillator.

Group Type: ACTIVE_COMPARATOR

Subcutaneous Implantable Cardioverter Defibrillator

Intervention Type: DEVICE

The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

Interventions

Subcutaneous Implantable Cardioverter Defibrillator

The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentina Kutyifa, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Heart Research Follow-up Program

Locations

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

Ohio Health Research Institute

Columbus, Ohio, United States

Promedica Toledo Hospital

Toledo, Ohio, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Phoenixville Hospital

Phoenixville, Pennsylvania, United States

University of Pittsburgh Medical Center - Presbyterian

Pittsburgh, Pennsylvania, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

University of Texas, Houston

Houston, Texas, United States

Sentara Norfolk General

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Medizinische Hochschule Hannover

Hannover, Lower Saxony, Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

Universitaetsklinik Eppendorf

Hamburg, , Germany

Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Ospedale Niguarda CA Granda

Milan, Niguarda, Italy

Azienda Ospedaliera Universitaria

Verona, , Italy

UMC Utrecht

Utrecht, CX, Netherlands

Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

University of Navarra, Department of Cardiology

Pamplona, Navarre, Spain

University Hospital Zurich

Zurich, , Switzerland

Countries

United States; Germany; Israel; Italy; Netherlands; Spain; Switzerland

References

Kutyifa V, Beck C, Brown MW, Cannom D, Daubert J, Estes M, Greenberg H, Goldenberg I, Hammes S, Huang D, Klein H, Knops R, Kosiborod M, Poole J, Schuger C, Singh JP, Solomon S, Wilber D, Zareba W, Moss AJ; MADIT S-ICD Executive Committee. Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol. Am Heart J. 2017 Jul;189:158-166. doi: 10.1016/j.ahj.2017.04.014. Epub 2017 May 4.

Reference Type: BACKGROUND

PMID: 28625372 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MADIT S-ICD (C1834)

Identifier Type: -

Identifier Source: org_study_id