At a glance
ClinicalIndex Comparison Record- ✓Age ≥65 years at consent
- ✓Diabetes mellitus treated with oral or injectable agents (non-insulin or insulin) for ≥3 months prior to consent
- ✓LVEF 36-50% documented within 12 months before consent and ≥3 months after most recent MI, PCI, or CABG
- ✓One or more documented, enzyme-positive myocardial infarctions more than 3 months prior to consent (or evidence of silent MI with pathologic Q waves or imaging)
- ✕LVEF >50% or <36% within 12 months prior to consent and ≥3 months after most recent MI/PCI/CABG
- ✕Existing guideline-based indication for ICD, pacemaker, CRT, or CRT-D
- ✕Prior ICD, CRT, CRT-D, or pacemaker implantation
- ✕Active infection at time of consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD)
In Brief
A clinical study evaluating Subcutaneous Implantable Cardioverter Defibrillator for Tachycardia and 2 related conditions. Completed, enrolled 40 participants across 49 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.