Sudden Cardiac DeathPhase 4PredictionNCT00560768
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
A Phase 4 study testing Ovatio VR 6250 or DR6550 in people with Sudden Cardiac Death, run by LivaNova at 30 sites in 4 countries.
Trial summary
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- Ovatio VR 6250 or DR6550
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 30 sitesin 4 countries
- Study dates
- Dec 2007to Oct 2012
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines
- CHF since > 3 months and
- LVEF < 35% and
- NYHA class II or III
- OR
- Prior Myocardial infarction since more than 4 weeks and
- LVEF < 30%
Who cannot join
- Documented spontaneous sustained ventricular tachycardia
- Prior implant of any device for ventricular cardiac pacing
- Existing indication for permanent ventricular pacing
- Myocardial infarction within 4 weeks prior to enrollment
- Arrhythmogenic RV-Dysplasia
- Brugada syndrome
Show all 19Show fewer
- Long QT syndrome
- Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical)
- Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
- Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient
- Permanent chronic atrial fibrillation / flutter
- Patient is unable to attend the scheduled follow-up visits at the participating centre
- Patient is already included in another ongoing clinical study
- Patient is unable to understand the objectives of the study
- Patient refuses to cooperate
- Patient is unable or refuses to provide informed consent
- Patient is minor (less than 18-year old)
- Patient has life expectancy of less than 1 year
- Patient is pregnant.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
Germany18 sites
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, D-32545
Praxis Westend
Berlin, 10050
Universitatsklinik Krankenanstalten Bergmannsheil
Bochum, 44789
Medizinische Universitatsklinik
Bonn, D-53127
Klinikum
Coburg, 96450
Landkrankhenhaus Coburg
Coburg, 96450
Evangelisches Krankenhaus
Düsseldorf, 40217
Evangelisches Krankhenhaus Düsseldorf
Düsseldorf, 40217
Kardiocentrum
Frankfurt, 60316
Kardiocentrum Frankfurt, Klinik Rotes Kreuz
Frankfurt, D-60316
Städt Klinikum Lüneburg
Lüneburg, 21339
Johannes Gutenberg-Universitat
Mainz, 55101
Universitatklinikum Mainz
Mainz, D-55101
Bogenhausen Städt. Krankenhaus
München, 81925
Krankenhaus Reinbeck St Adolf-Stift
Reinbeck, 21465
ST. Adolf Stift; Medizinische Klinik
Reinbek, 21465
Universitätsklinikum Würzburg
Würzburg, 97080
Medizinische Klinik und Poliklinik I / kardiologie
Würzburg, D-97080
United States7 sites
Piedmont Hospital
Atlanta, Georgia, 30309
CMC - NorthEast
Charlotte, North Carolina, 28025
Stafford M. Smith - Scranton Heart Institute
Clarks Green, Pennsylvania, 18411-2326
Easton Cardiology
Easton, Pennsylvania, 18042
Helen Kelle Hospital
Sheffield, Alabama, 35660
Valley Regional Arrhytmia Center
Tarzana, California, 91356
Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615
Canada4 sites
Grey-Nuns Hospital
Edmonton, X0C0B0
Hotel-Dieu du CHUM
Montreal, H2W1T8
Laval UH, Ste Foy
Québec, G1V4G5
St. Michael's Hospital
Toronto, M5B1W8
About this study
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Conditions
- Sudden Cardiac Death
- Being tested
- Ovatio VR 6250 or DR6550
- Keywords
- Risk stratification method, negative predictive value, fast ventricular arrhythmias, ICD, The negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovatio VR 6250 or DR6550Device
The study requires the implantation of locally approved material:
- A right ventricular defibrillation lead
- In case of use of a dual chamber ICD a right atrial pacing lead
- A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study.
Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Ovatio VR 6250 or DR6550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAV score and number of tachyarrhythmic events.
Measured: The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases.
Secondary outcomes (1)
TAV change
Measured: 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- BRACHMANN Johannes, PhD, Principal investigator, Klinikum Coburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560768
- Sponsor's protocol ID
- Prediction - ITAC06 Eu
- Other IDs
- ITAC06 Eu
- Acronym
- Prediction
- Status last verified
- Jan 2015
- First submitted
- 19 Nov 2007
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
- ClinicalTrials.gov ID
- NCT00560768
- Acronym / sponsor ID
- Prediction / Prediction - ITAC06 Eu
- Conditions
- Sudden Cardiac Death
- Keywords
- Risk stratification method, negative predictive value, fast ventricular arrhythmias, ICD, The negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Nov 2007 (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 aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Ovatio VR 6250 or DR6550 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines
- CHF since > 3 months and
- LVEF < 35% and
- NYHA class II or III
- OR
Key exclusion criteria (19 listed)
- Documented spontaneous sustained ventricular tachycardia
- Prior implant of any device for ventricular cardiac pacing
- Existing indication for permanent ventricular pacing
- Myocardial infarction within 4 weeks prior to enrollment
- Arrhythmogenic RV-Dysplasia
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 |
|---|---|---|
| Ovatio VR 6250 or DR6550The study requires the implantation of locally approved material: * A right ventricular defibrillation lead * In case of use of a dual chamber ICD a right atrial pacing lead * A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study. Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar. | Device | 1 |
Primary outcome
TAV score and number of tachyarrhythmic events.
Time frame: The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases.
1 secondary outcome
TAV change
Time frame: 12 months of follow up
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 12 Jan 2015.
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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.
BRACHMANN Johannes, PhD principal investigator
Klinikum Coburg
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ovatio VR 6250 or DR6550 in people with Sudden Cardiac Death, run by LivaNova at 30 sites in 4 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 7 inclusion and 19 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 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, United States, Canada, Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
TAV score and number of tachyarrhythmic events. (time frame: The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2015.