{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T04:05:10Z","timestamp":1771301110325,"version":"3.50.1"},"reference-count":30,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,1,15]],"date-time":"2017-01-15T00:00:00Z","timestamp":1484438400000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008497","name":"Boston Scientific Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008497","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pacing Clinical Electrophis"],"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S\u2010ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)\u2010free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results<\/jats:title><jats:p>The UNTOUCHED study is a global, multicenter, prospective, nonrandomized study of patients undergoing <jats:italic>de novo<\/jats:italic> S\u2010ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF \u226435%. 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\u2010RIT. The secondary end points are all\u2010cause shock\u2010free rate at 18 months, and system\u2010 and procedure\u2010related complication\u2010free 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This trial will provide important data regarding the rates of inappropriate and appropriate shock therapy in real\u2010world use of the S\u2010ICD in the most common group of patients receiving ICDs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pace.12994","type":"journal-article","created":{"date-parts":[[2016,12,10]],"date-time":"2016-12-10T12:50:14Z","timestamp":1481374214000},"page":"1-8","source":"Crossref","is-referenced-by-count":24,"title":["The Design of the Understanding Outcomes with the S\u2010ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED)"],"prefix":"10.1111","volume":"40","author":[{"given":"MICHAEL R.","family":"GOLD","sequence":"first","affiliation":[{"name":"Department of Medicine Medical University of South Carolina  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