Ventricular TachyarrhythmiaNCT01282918
NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
A study testing ICD implantation w/o DF test and ICD implantation with DF test in people with Ventricular Tachyarrhythmia, run by Biotronik SE & Co. KG at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachyarrhythmia
- What is being tested?
- ICD implantation w/o DF test and ICD implantation with DF test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,077 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial
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.
Read the 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).
- Conditions
- Ventricular Tachyarrhythmia
- Being tested
- ICD implantation w/o DF test, ICD implantation with DF test
- Keywords
- ICD, DF Test, intra-operative DF testing, VT
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD implantation w/o DF testDevice
ICD implantation without Defibrillation Test
ICD implantation with DF testDevice
ICD implantation with DF test according to standardized procedure
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Patients without DF (Defibrillation) testing during ICD implantation Receives: Device: ICD implantation w/o DF test |
| Control group | Other | Patients with DF testing during ICD implantation (according to standardized procedure) Receives: Device: ICD implantation with DF test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
Follow-Up and efficacy endpoints
- All-cause mortality
- Cardiac mortality
- Arrhythmic mortality
- Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dietmar Bänsch, Prof. Dr. med., Principal investigator, Rostock University HospitalJohan Brandt, PhD, MD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282918
- Sponsor's protocol ID
- NORDIC -1.1
- Status last verified
- Jun 2015
- First submitted
- 18 Jan 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25107947
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial
- ClinicalTrials.gov ID
- NCT01282918
- Acronym / sponsor ID
- NORDIC -1.1
- Conditions
- Ventricular Tachyarrhythmia
- Keywords
- ICD, DF Test, intra-operative DF testing, VT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Device: ICD implantation w/o DF testPatients without DF (Defibrillation) testing during ICD implantation |
| Control group | Other | Device: ICD implantation with DF testPatients with DF testing during ICD implantation (according to standardized procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD implantation w/o DF testICD implantation without Defibrillation Test | Device | Study group |
| ICD implantation with DF testICD implantation with DF test according to standardized procedure | Device | Control group |
Primary outcome
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.
2 secondary outcomes
Procedural and safety endpoints
Time frame: 12 months
Follow-Up and efficacy endpoints
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Background: PubMed 25107947Bansch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dietmar Bänsch, Prof. Dr. med. principal investigator
Rostock University Hospital
Johan Brandt, PhD, MD principal investigator
Skane University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD implantation w/o DF test and ICD implantation with DF test in people with Ventricular Tachyarrhythmia, run by Biotronik SE & Co. KG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average efficacy of the first ICD shock for all true ventricular tachyarrhythmias (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.