NCT01282918

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,077

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

January 18, 2011

Last Update Submit

June 22, 2015

Conditions

Ventricular Tachyarrhythmia

Keywords

ICDDF Testintra-operative DF testingVT

Outcome Measures

Primary Outcomes (1)

  • Average efficacy of the first ICD shock for all true ventricular tachyarrhythmias

    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.

    12 months

Secondary Outcomes (2)

  • Procedural and safety endpoints

    12 months

  • Follow-Up and efficacy endpoints

    12 months

Study Arms (2)

Study group

OTHER

Patients without DF (Defibrillation) testing during ICD implantation

Device: ICD implantation w/o DF test

Control group

OTHER

Patients with DF testing during ICD implantation (according to standardized procedure)

Device: ICD implantation with DF test

Interventions

ICD implantation w/o DF testDEVICE

ICD implantation without Defibrillation Test

Study group
ICD implantation with DF testDEVICE

ICD implantation with DF test according to standardized procedure

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Rostock

Rostock, 18057, Germany

Location

Arrhythmia Department Skane University Hospital

Lund, S-221 85, Sweden

Location

Related Publications (1)

  • Bansch D, Bonnemeier H, Brandt J, Bode F, Svendsen JH, Felk A, Hauser T, Wegscheider K; NORDIC ICD Trial Investigators. 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. 2015 Jan;17(1):142-7. doi: 10.1093/europace/euu161. Epub 2014 Aug 8.

    PMID: 25107947BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dietmar Bänsch, Prof. Dr. med.

    Rostock University Hospital

    PRINCIPAL INVESTIGATOR

  • Johan Brandt, PhD, MD

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 25, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

SE(1)DE(1)