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

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ClinicalTrials.gov Identifier: NCT02787785
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE April 17, 2017
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 26, 2016)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
Official Title  ICMJE Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tachycardia
  • Diabetes Mellitus
  • Cardiovascular Disease
Intervention  ICMJE Device: Subcutaneous Implantable Cardioverter Defibrillator
The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Subcutaneous Implantable Cardioverter Defibrillator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2016)
1800
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Israel,   Italy,   Netherlands,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787785
Other Study ID Numbers  ICMJE MADIT S-ICD (C1834)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE University of Rochester
Investigators  ICMJE
Principal Investigator: Valentina Kutyifa, MD, MSc, PhD University of Rochester Heart Research Follow-up Program
PRS Account Boston Scientific Corporation
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP