Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)
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| ClinicalTrials.gov Identifier: NCT02787785 |
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Recruitment Status :
Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : September 2, 2020
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Sponsor:
Boston Scientific Corporation
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Boston Scientific Corporation
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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 |
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 : | 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
MedlinePlus related topics:
Pacemakers and Implantable Defibrillators
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Conventional Medical Therapy
This arm of the trial continues with their current conventional medical therapy.
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Active Comparator: Subcutaneous Implantable Cardioverter Defibrillator
This arm of the trial receives a subcutaneous implantable defibrillator.
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Device: Subcutaneous Implantable Cardioverter Defibrillator
The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator. |
Primary Outcome Measures :
- 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 :
- 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.
Other Outcome Measures:
- 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
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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 49 study locations
Sponsors and Collaborators
Boston Scientific Corporation
University of Rochester
Investigators
| Principal Investigator: | Valentina Kutyifa, MD, MSc, PhD | University of Rochester Heart Research Follow-up Program |
| 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: | September 2, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Keywords provided by Boston Scientific Corporation:
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Subcutaneous Implantable Cardioverter Defibrillator MADIT Diabetes Myocardial Infarction |
Additional relevant MeSH terms:
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Cardiovascular Diseases Tachycardia Arrhythmias, Cardiac |
Heart Diseases Cardiac Conduction System Disease Pathologic Processes |