NORDIC ICD (Cardioverter Defibrillator Implantation) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282918
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief Summary:
The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF testing regarding the efficacy of the first ICD shock for the treatment of true spontaneous ventricular tachyarrhythmias.

Condition or disease Intervention/treatment Phase
Ventricular Tachyarrhythmia Device: ICD implantation w/o DF test Device: ICD implantation with DF test Not Applicable

Detailed Description:

The NORDIC ICD study is justified by the need to compare the clinical outcome between patients that did receive defibrillation (DF) testing and those who did not receive DF testing during ICD implantation. The NORDIC ICD study will evaluate the impact of intra-operative DF testing on the long-term ICD first shock efficacy for true ventricular tachyarrhythmias in the observational period. Therefore, the primary analysis of this study will consider all ventricular tachyarrhythmia episodes treated by ICD shock(s) during the trial follow-up period.

Moreover, the Home MonitoringTM system of BIOTRONIK will be used in order to monitor the technical system integrity, device programming and cardiac performance continuously. It supports early information about the occurrence of VT/VF (Ventricular Tachycardia/Ventricular Fibrillation) episodes and corresponding therapies such as ICD shocks. The Home MonitoringTM capability offered by active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of cardiac performance.

1077 patients were enrolled and randomized (1:1) in 48 centers in five European countries (Germany, Czech Republic, Denmark, Sweden and Latvia).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1077 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial
Study Start Date : February 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Study group
Patients without DF (Defibrillation) testing during ICD implantation
Device: ICD implantation w/o DF test
ICD implantation without Defibrillation Test

Control group
Patients with DF testing during ICD implantation (according to standardized procedure)
Device: ICD implantation with DF test
ICD implantation with DF test according to standardized procedure

Primary Outcome Measures :
  1. Average efficacy of the first ICD shock for all true ventricular tachyarrhythmias [ Time Frame: 12 months ]
    The primary endpoint is the average efficacy of the first ICD shock for all true ventricular tachyarrhythmias of a patient in the observational period. More precisely, the primary endpoint will be determined as the number of true ventricular tachyarrhythmias of a patient (that were efficiently terminated by the first shock delivered by the ICD) divided by the number of true ventricular tachyarrhythmias (treated with at least one ICD shock) of the same patient.

Secondary Outcome Measures :
  1. Procedural and safety endpoints [ Time Frame: 12 months ]
    • Serious adverse events associated with the implantation procedure
    • Optional assessment of blood parameters indicating myocardial injury BNP (B-TYPE NATRIURETIC PEPTIDE), Creatinine, Troponin T, CK (Creatin-Kinase), CK-MB (Creatin-Kinase-MB)
    • Frequency of system revisions at implant, such as repositioning of leads, reprogramming the device to reverse polarity
    • Total fluoroscopy and implantation time

  2. Follow-Up and efficacy endpoints [ Time Frame: 12 months ]
    • All-cause mortality
    • Cardiac mortality
    • Arrhythmic mortality
    • Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death and the 2010 focused update of ESC guidelines on device therapy in heart failure (Class I recommendations)
  • Primary or secondary prophylaxis
  • First ICD implantation with no pre/existing or previous ICD therapy or ICD system
  • The patient is willing and able to comply with the clinical investigation plan
  • Patient has signed informed consent

Exclusion Criteria:

  • Age ≤ 18 years
  • ARVC or hypertrophic cardiomyopathy
  • VF due to acute ischemia or other potentially reversible causes
  • Actively listed for a transplant
  • Unable or unwilling to participate in the study
  • Unavailable for required follow-ups and study procedures
  • Participating in another clinical study other than a registry or observational/non-interventional study
  • Anticipated right sided implantation of ICD generator
  • Malignant condition with a life expectancy less than the duration of the study
  • Pregnant and breast-feeding women
  • Terminal renal insufficiency
  • Persistent AF without pre-operative TEE (Transesophageal echocardiography)
  • Persistent AF with left atrial thrombus diagnosed by TEE

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01282918

Universitätsklinikum Rostock
Rostock, Germany, 18057
Arrhythmia Department Skane University Hospital
Lund, Sweden, S-221 85
Sponsors and Collaborators
Biotronik SE & Co. KG
Principal Investigator: Dietmar Bänsch, Prof. Dr. med. Rostock University Hospital
Principal Investigator: Johan Brandt, PhD, MD Skane University Hospital

Additional Information:
Responsible Party: Biotronik SE & Co. KG Identifier: NCT01282918     History of Changes
Other Study ID Numbers: NORDIC -1.1
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Biotronik SE & Co. KG:
DF Test
intra-operative DF testing

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes