title: The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial: concept and design of a randomized, controlled trial of intra-operative defibrillation testing during de novo defibrillator implantation.
abstract: OBJECTIVE
  Although defibrillation (DF) testing is still considered a standard procedure during implantable cardioverter-defibrillator (ICD) insertion and has been an essential element of all trials that demonstrated the survival benefit of ICD therapy, there are no large randomized clinical trials demonstrating that DF testing improves clinical outcome and if the outcome would remain the same by omitting DF testing.
  
  
  RESULTS
  Between February 2011 and July 2013, we randomly assigned 1077 patients to ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres. After inducing a fast ventricular tachycardia (VT) with a heart rate ≥240 b.p.m. or ventricular fibrillation (VF) with a low-energy T-wave shock, DF was attempted with an initial 15 J shock. If the shock reversed the VT or VF, DF testing was considered successful and terminated. If unsuccessful, two effective 24 J shocks were administered. If DF was unsuccessful, the system was reconfigured and another DF testing was performed. An ICD shock energy of 40 J had to be programmed in all patients for treatment of spontaneous VT/VF episodes. The primary endpoint was the average efficacy of the first ICD shock for all true VT/VF episodes in each patient during follow-up. The secondary endpoints included the frequency of system revisions, total fluoroscopy, implantation time, procedural serious adverse events, and all-cause, cardiac, and arrhythmic mortality during follow-up. Home Monitoring was used in all patients to continuously monitor the system integrity, device programming and performance.
  
  
  CONCLUSIONS
  The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation (NORDIC ICD) trial is one of two large prospective randomized trials assessing the effect of DF testing omission during ICD implantation.
  
  
  BACKGROUND
  NCT01282918.
authors.affiliation: Heart Center Rostock, Department of Internal Medicine I, Divisions of Cardiology, University Hospital Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany dietmar.baensch@med.uni-rostock.de.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Bänsch
authors.affiliation: Department of Internal Medicine III Cardiology and Angiology, University Hospital Schleswig-Holstein, campus Kiel, 24105 Kiel, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Bonnemeier
authors.affiliation: Arrhythmia Department, Skane University Hospital, S-221 85 Lund, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Brandt
authors.affiliation: Medical Clinic II Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, campus Lübeck, 23538 Lübeck, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Bode
authors.affiliation: Heart Center, Department of Cardiology, Rigshospitalet Copenhagen University Hospital, DK-2100 Copenhagen, Denmark Danish Arrhythmia Research Centre, University of Copenhagen, DK-2200 Copenhagen, Denmark.
authors.forename: Jesper Hastrup
authors.initials: JH
authors.lastname: Svendsen
authors.affiliation: Clinical Affairs & Reimbursement CENEMEA, Biotronik Berlin, 12359 Berlin, Germany.
authors.forename: Angelika
authors.initials: A
authors.lastname: Felk
authors.affiliation: Clinical Affairs & Reimbursement CENEMEA, Biotronik Berlin, 12359 Berlin, Germany.
authors.forename: Tino
authors.initials: T
authors.lastname: Hauser
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg Eppendorf, 20246 Hamburg, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017147:Defibrillators, Implantable; D019544:Equipment Failure Analysis / Q000379:methods*; D005060:Europe; D005260:Female; D006333:Heart Failure / Q000175:diagnosis* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
keywords: Defibrillation testing; Implantable cardioverter-defibrillator