NORDIC ICD (Cardioverter Defibrillator Implantation) Trial

Ventricular Tachyarrhythmia Clinical Trial

Official title:

NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282918
• Other study ID #: NORDIC -1.1
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: June 22, 2015
• Start date: February 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia, Ventricular
• Ventricular Tachyarrhythmia

Intervention

Device:
• ICD implantation w/o DF test
ICD implantation without Defibrillation Test
• ICD implantation with DF test
ICD implantation with DF test according to standardized procedure

Locations

Country	Name	City	State
Germany	Universitätsklinikum Rostock	Rostock
Sweden	Arrhythmia Department Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Germany,  Sweden, 

References & Publications (1)

Bänsch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Procedural and safety endpoints	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	12 months	Yes
Secondary	Follow-Up and efficacy endpoints	All-cause mortality; Cardiac mortality; Arrhythmic mortality; Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy	12 months	No

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