NORDIC-ICD

NORDIC ICD

The NO Regular Defibrillation testing In Cardioverter Defibrillator Implantation trial

Bänsch et al., European Heart Journal 2015

Study Design

  • Prospective, randomized, parallel group, multicenter, non-inferiority study 1
  • Investigates the effect of defibrillation (DF) testing at the time of de novo ICD implantation on first shock efficacy during follow-up
  • 1,077 (540 with and 537 without DF test) ICD and CRT-D patients at 48 centers in five countries

Key Result 1

Defibrillation (DF) testing during implantation does not improve defibrillation efficacy during follow-up, nor all-cause mortality (median 22.8 months).2

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Garph of Defibrillation (DF) testing

Key Result 2

DF testing, or the various measures to improve defibrillation efficacy, lengthen the procedure, and may even be harmful.2

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Graph of Defibrillation DF Testing

Clinical Relevance

  • Results do not support the routine use of DF testing during first time ICD implantation on the left side
  • Implantation strategy without DF testing should be preferred
  • Results confirm the safety of omitting the DF test, which is currently routine clinical practice in many implanting centers all over the world

Study Objective
  • Investigation of the effect of defibrillation (DF) testing at the time of de novo ICD implantation on first shock efficacy (FSE) during follow-up
1° Endpoints
  • Average efficacy of the first ICD shock for all true ventricular tachyarrhythmias
2 ° Endpoints
  • Serious adverse events associated with the implantation procedure
  • Frequency of system revisions at implant, such as repositioning of leads, reprogramming the device to reverse polarity
  • Total fluoroscopy and implantation time
  • All-cause mortality
  • Cardiac mortality
  • Arrhythmic mortality
  • Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy
Clinical Sites
  • 48 centers in five European countries (DEU, SWE, DNK, CZE, LVA)
Sample Size
  • 1,077 patients (1:1 randomization)
Inclusion Criteria
  • Indication for implantation of a single chamber ICD, dual chamber ICD and CRT-D therapy according to the ACC/AHA/ESC 2006 guidelines
  • Primary or secondary prophylaxis
  • First ICD implantation with no preexisting or previous ICD therapy or ICD system
Main Exclusion Criteria
  • Age K 18 years
  • ARVC or hypertrophic cardiomyopathy
  • Anticipated right sided implantation of ICD generator
  • Terminal renal insufficiency
  • Persistent AF without pre-operative TEE (Transesophageal echocardiography)
  • Persistent AF with left atrial thrombus diagnosed by TEE
Devices
  • All BIOTRONIK Lumax/Ilesto/Iforia ICD (VR-T, VR-T DX, DR-T, and HF-T) with 40J max. shock energy
  • The choice of the electrode manufacturer was at the discretion of the investigator. Lead type (single/dual coil) had to be defined before randomization
Study FlowchartStudy Flow Chart NORDIC ICD
Follow-Up
  • At least 12 months through regular on-site visits, and remotely via BIOTRONIK Home Monitoring®
Study Duration
  • February 2011 – May 2015
Reference no.
  • NCT01282918
Principal Investigators
  • Prof. Dr. med. Dietmar Bänsch, Rostock University Hospital, Germany
  • Johan Brandt, PhD, MD, Skane University Hospital, Sweden


1 Bänsch D, Bonnemeier H, Brandt J, Bode F, Svendsen JH, Felk A, Hauser T, Wegscheider K; 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, Europace, Jan 2015;17(1):142-7.

2 Bänsch D, Bonnemeier H, Brandt J, Bode F, Svendsen JH, Táborský M, Kuster S, Blomström-Lundqvist C, Felk A, Hauser T, Suling A, Wegscheider K; Intra-Operative Defibrillation Testing and Clinical Shock Efficacy in Patients with Implantable Cardioverter-Defibrillators: The NORDIC ICD Randomised Clinical Trial, European Heart Journal Jun 2015, DOI: 10.1093/eurheartj/ehv292.