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

Status: Active, not recruiting
Location: See all (49) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The MADIT S-ICD trial is 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: No
View:

• 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

Locations
United States
Alabama
Heart Center Research, LLC.
Huntsville
Arkansas
St. Bernard's Medical Center
Jonesboro
Arizona
Mayo Clinic- Scottsdale
Scottsdale
California
Glendale Adventist Medical Center
Glendale
Cedar-Sinai Medical Center
Los Angeles
University of Southern California
Los Angeles
Alta Bates Summit Hospital
Oakland
Huntington Hospital
Pasadena
Florida
Tallahassee Research Institute
Tallahassee
Georgia
Emory University
Atlanta
Iowa
University of Iowa
Iowa City
Illinois
Loyola University Medical Center
Maywood
Kentucky
St. Elizabeth Healthcare
Edgewood
University of Louisville
Louisville
Louisiana
Advanced Cardiovascular Specialists
Shreveport
Massachusetts
Tufts Medical Center
Boston
Michigan
Henry Ford Hospital
Detroit
Missouri
Saint Luke's Hospital
Kansas City
North Carolina
North Carolina Heart and Vascular
Raleigh
Nebraska
Nebraska Heart Institute
Lincoln
New Hampshire
Catholic Medical Center
Manchester
New Jersey
Cardiovascular Associates of Delaware Valley
Haddon Heights
New York
Northwell Health
Manhasset
Strong Memorial / University of Rochester Medical Center
Rochester
Ohio
Ohio Health Research Institute
Columbus
Ohio State Wexner Medical Center
Columbus
Promedica Toledo Hospital
Toledo
Pennsylvania
Abington Memorial Hospital
Abington
Phoenixville Hospital
Phoenixville
University of Pittsburgh Medical Center - Presbyterian
Pittsburgh
Tennessee
Erlanger Medical Center
Chattanooga
Texas
University of Texas, Houston
Houston
Virginia
Sentara Norfolk General
Norfolk
Virginia Commonwealth University
Richmond
Washington
University of Washington
Seattle
PeaceHealth Southwest Medical Center
Vancouver
Other Locations
Germany
Unfallkrankenhaus Berlin
Berlin
Universitaetsklinik Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hannöver
Israel
Hadassah Hebrew University Medical Center
Jerusalem
Kaplan Medical Center
Rechovot
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Azienda Ospedaliera Ospedale Niguarda CA Granda
Milano
Azienda Ospedaliera Universitaria
Verona
Netherlands
Academisch Medisch Centrum
Amsterdam
UMC Utrecht
Utrecht
Spain
University of Navarra, Department of Cardiology
Pamplona
Hospital Universitario Miguel Servet
Zaragosa
Switzerland
University Hospital Zurich
Zürich
Time Frame
Start Date: April 17, 2017
Estimated Completion Date: October 2023
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Rochester
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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