1. The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED)
- Author
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Gold, Michael R., Knops, Reinoud, Burke, Martin C., Lambiase, Pier D., Russo, Andrea M., Bongiorni, Maria Grazia, Deharo, Jean-Claude, Aasbo, Johan, El Chami, Mikhael F., Husby, Michael, Carter, Nathan, Boersma, Lucas, Royal Holloway [University of London] (RHUL), The Heart Hospital [London], University College of London [London] (UCL), Dysoxie, suractivité : aspects cellulaires et intégratifs thérapeutiques (DS-ACI / UMR MD2), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département de Cardiologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital de la Timone [CHU - APHM] (TIMONE)-Assistance Publique - Hôpitaux de Marseille (APHM), Amsterdam Cardiovascular Sciences, Cardiology, and ACS - Heart failure & arrhythmias
- Subjects
[SDV]Life Sciences [q-bio] - Abstract
International audience; Abstract BackgroundThe UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S‐ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)‐free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. Methods and ResultsThe UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing de novo S‐ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%. The primary end point of this trial is freedom from IAS at 18 months. The lower 95% confidence bound of the observed incidence will be compared to a performance goal of 91.6%, which was derived from the IAS rate in MADIT‐RIT. The secondary end points are all‐cause shock‐free rate at 18 months, and system‐ and procedure‐related complication‐free rate at 1 month and 6 months. Enrollment of a minimum of 1,100 subjects from up to 200 centers worldwide is planned based on power calculations of the primary and principal secondary end points. ConclusionsThis trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real‐world use of the S‐ICD in the most common group of patients receiving ICDs.
- Published
- 2017