N/A
N=40
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
Tachycardia · Diabetes Mellitus · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02787785 ↗Enrolled (actual)
40
Serious AEs
70.0%
Results posted
Aug 2024
Primary outcome: Primary: All-Cause Mortality — 3; 4 Participants — p=0.354
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Subcutaneous Implantable Cardioverter Defibrillator (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-Cause Mortality |
3; 4 | 0.354 |
| SECONDARY All-Cause Mortality in Various Subgroups |
3; 2; 0; 2; 3; 3 | — |
| SECONDARY Sudden Death |
1; 1 | 0.479 |
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.
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 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 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
Data sourced from ClinicalTrials.gov (NCT02787785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.