title: Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial.
abstract: OBJECTIVE
  Implantable cardioverter defibrillators (ICD) can prevent sudden cardiac death by delivering high-energy shocks in patients at risk of life-threatening ventricular tachyarrhythmias. Patients may be anxious about receiving inappropriate shocks in case of device or lead system malfunction, or about failing to receive needed therapy for the same reason. New devices include programmable vibrating patient notifiers (PN), which, by warning patients of a possible device dysfunction, might lower device-related anxiety. PAtient NOtifier feature for Reduction of Anxiety: a Multicentre ICD study (PANORAMIC) is a multicentre, randomized, clinical trial designed to examine the effects of the awareness of an active vibrating alert system on device-related anxiety.
  
  
  METHODS
  The trial will randomly assign 356 patients in a 1:1 design to a control group (PN OFF) vs. a treatment group (PN ON). Patients will be followed for 12 months, with visits scheduled at 6 and 12 months. During clinical follow-up visits, the ICD will be interrogated, and all patients will complete the Hospital Anxiety and Depression Scale and a device-related anxiety questionnaire. The sensitivity and specificity of PN, the effect of personality on anxiety, using the Type D scale (DS14), the number of delivered appropriate and inappropriate ICD therapies, changes in anxiety related to the delivery of appropriate or inappropriate shocks, crossovers from the assigned group, the number of hospitalizations, and the mortality rate will also be assessed. ClinicalTrials.gov Identifier: NCT00559559.
authors.affiliation: University Hospital Zurich, Clinic for Cardiology, Rämistrasse 100, CH-8091 Zurich, Switzerland. firat.duru@usz.ch
authors.forename: Firat
authors.initials: F
authors.lastname: Duru
authors.forename: Paul
authors.initials: P
authors.lastname: Dorian
authors.forename: Stefano
authors.initials: S
authors.lastname: Favale
authors.forename: Christian
authors.initials: C
authors.lastname: Perings
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Pedersen
authors.forename: Vincent
authors.initials: V
authors.lastname: Willems
mesh_terms: D001007:Anxiety / Q000517:prevention & control*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D017147:Defibrillators, Implantable / Q000523:psychology*; D023381:Endpoint Determination; D004868:Equipment Failure; D005500:Follow-Up Studies; D006801:Humans; D050316:Medical Order Entry Systems; D008991:Monitoring, Physiologic / Q000295:instrumentation*; D012307:Risk Factors; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires; D017180:Tachycardia, Ventricular / Q000453:epidemiology