title: The Design of the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED).
abstract: BACKGROUND
  The 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  This 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.
authors.affiliation: Department of Medicine, Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Gold
authors.affiliation: Department of Electrophysiology, Academisch Medisch Centrum, Amsterdam, The Netherlands.
authors.forename: Reinoud
authors.initials: R
authors.lastname: Knops
authors.affiliation: Corvita Health & Science, Chicago, Illinois.
authors.forename: Martin C
authors.initials: MC
authors.lastname: Burke
authors.affiliation: Institute of Cardiovascular Science, UCL, Barts Heart Centre & University College, London, UK.
authors.forename: Pier D
authors.initials: PD
authors.lastname: Lambiase
authors.affiliation: Electrophysiology and Arrhythmia Services, Cooper University Hospital, Camden, New Jersey.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Russo
authors.affiliation: Division of Cardiology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bongiorni
authors.affiliation: Cardiologie & Rythmologie Division, CHU La Timone Hospital, Marseille, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Deharo
authors.affiliation: Cardiac Electrophysiology Laboratories, The Toledo Hospital, Toledo, Ohio.
authors.forename: Johan
authors.initials: J
authors.lastname: Aasbo
authors.affiliation: Division of Cardiology, Section of Cardiac Electrophsyiology, Emory Heart and Vascular Center, Atlanta, Georgia.
authors.forename: Mikhael F
authors.initials: MF
authors.lastname: El Chami
authors.affiliation: Boston Scientific Corporation, St. Paul, Minnesota.
authors.forename: Michael
authors.initials: M
authors.lastname: Husby
authors.affiliation: Boston Scientific Corporation, St. Paul, Minnesota.
authors.forename: Nathan
authors.initials: N
authors.lastname: Carter
authors.affiliation: Hartcentrum, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
authors.forename: Lucas
authors.initials: L
authors.lastname: Boersma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004556:Electric Injuries / Q000209:etiology* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D012107:Research Design; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
keywords: VT; clinical trials; defibrillation-ICD; heart failure