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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787785
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Tachycardia Diabetes Mellitus Cardiovascular Disease Device: Subcutaneous Implantable Cardioverter Defibrillator Not Applicable

Detailed Description:
In this study, subjects will be randomized to receive a subcutaneous implantable cardioverter defibrillator or Conventional Medical Therapy (CMT). Randomization will be stratified by enrolling site, in a 2:1 (S-ICD:CMT) scheme. Length of follow-up for each subject will be dependent on the date of entry into the study, since all subjects will be followed to a common study termination date.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: Through study completion,estimated average of 2.6 years follow-up ]
    This study is event driven so there is no set end date for follow-up or analysis. Subjects will be followed until the statistical boundary is crossed.


Secondary Outcome Measures :
  1. All-Cause Mortality in various subgroups [ Time Frame: Through study completion,estimated average of 2.6 years follow-up ]
    This study is event driven so there is no set end date for follow-up or analysis. Subjects will be followed until the statistical boundary is crossed.

  2. Sudden Death in various subgroups [ Time Frame: Through study completion,estimated average of 2.6 years follow-up ]
    This study is event driven so there is no set end date for follow-up or analysis. Subjects will be followed until the statistical boundary is crossed.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787785


Locations
Show Show 49 study locations
Sponsors and Collaborators
Boston Scientific Corporation
University of Rochester
Investigators
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Principal Investigator: Valentina Kutyifa, MD, MSc, PhD University of Rochester Heart Research Follow-up Program

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02787785    
Other Study ID Numbers: MADIT S-ICD (C1834)
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Scientific Corporation:
Subcutaneous
Implantable Cardioverter Defibrillator
MADIT
Diabetes
Myocardial Infarction
Additional relevant MeSH terms:
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Tachycardia
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiac Conduction System Disease
Pathologic Processes