Back to resultsNORDIC ICD (Cardioverter Defibrillator Implantation) Trial
Primary Purpose
Ventricular Tachyarrhythmia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICD implantation w/o DF test
ICD implantation with DF test
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachyarrhythmia focused on measuring ICD, DF Test, intra-operative DF testing, VT
Eligibility 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
Sites / Locations
- Universitätsklinikum Rostock
- Arrhythmia Department Skane University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Study group
Control group
Arm Description
Patients without DF (Defibrillation) testing during ICD implantation
Patients with DF testing during ICD implantation (according to standardized procedure)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Follow-Up and efficacy endpoints
All-cause mortality
Cardiac mortality
Arrhythmic mortality
Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01282918
Brief Title
NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
Official Title
NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachyarrhythmia
Keywords
ICD, DF Test, intra-operative DF testing, VT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1077 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Other
Arm Description
Patients without DF (Defibrillation) testing during ICD implantation
Arm Title
Control group
Arm Type
Other
Arm Description
Patients with DF testing during ICD implantation (according to standardized procedure)
Intervention Type
Device
Intervention Name(s)
ICD implantation w/o DF test
Intervention Description
ICD implantation without Defibrillation Test
Intervention Type
Device
Intervention Name(s)
ICD implantation with DF test
Intervention Description
ICD implantation with DF test according to standardized procedure
Primary Outcome Measure Information:
Title
Average efficacy of the first ICD shock for all true ventricular tachyarrhythmias
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedural and safety endpoints
Description
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
Time Frame
12 months
Title
Follow-Up and efficacy endpoints
Description
All-cause mortality
Cardiac mortality
Arrhythmic mortality
Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietmar Bänsch, Prof. Dr. med.
Organizational Affiliation
Rostock University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johan Brandt, PhD, MD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Arrhythmia Department Skane University Hospital
City
Lund
ZIP/Postal Code
S-221 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
25107947
Citation
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.
Results Reference
background
Links:
URL
http://europace.oxfordjournals.org/content/17/1/142.long
Description
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NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
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