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Trial to study subcutaneous ICD in patients with diabetes, MI commences
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An international trial to study the survival benefit of a subcutaneous implantable cardioverter defibrillator system has begun enrolling patients, according to a press release from Boston Scientific.
The study, MADIT S-ICD, will enroll participants aged 65 years and older with a history of prior MI, diabetes and moderately reduced left ventricular ejection fraction to study subcutaneous ICD system (EMBLEM MRI, Boston Scientific). This population is at higher risk for sudden cardiac arrest, but is not currently guideline-recommended for implantable defibrillators, according to the release.
“Our hypothesis is that the [subcutaneous implantable defibrillator] device may reduce all-cause mortality in this high-risk cohort of cardiac patients with diabetes,” Valentina Kutyifa, MD, MS, PhD, FESC, FHRS, FACC, research assistant professor of cardiology at the University of Rochester Medical Center, said in the release. “The value of eliminating unnecessary patient complications by implanting a defibrillator which does not require intracardiac leads was an important factor in our decision to utilize the [subcutaneous ICD] when designing this trial.”
The researchers aim to enroll 1,800 individuals across 100 sites. According to the release, this trial is part of Boston Scientific’s WIN-Her Initiative, which aims to ensure adequate representation of women in clinical trials through women-focused recruiting materials.
Disclosure: Kutyifa reports receiving a research grant from Boston Scientific.