NORDIC ICD (NORDIC Implantable Cardioverter Defibrillator Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01282918
First received: January 18, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention
Ventricular Tachyarrhythmia
Device: ICD implantation w/o DF test
Device: ICD implantation with DF test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NORDIC Implantable Cardioverter Defibrillator Study

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Average efficacy of the first ICD shock for all true ventricular tachyarrhythmias [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Procedural and safety endpoints [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • 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

  • Follow-Up and efficacy endpoints [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • All-cause mortality
    • Cardiac mortality
    • Arrhythmic mortality
    • Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy


Enrollment: 1080
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

The minimum number of patients needed for this study is 1080 patients in approximately 40 centers mainly in Germany, Denmark, Sweden, Norway and Finland.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282918

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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01282918     History of Changes
Other Study ID Numbers: NORDIC -1.0
Study First Received: January 18, 2011
Last Updated: January 28, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 22, 2014