Ventricular Tachycardia, Ventricular FibrillationCogent-4NCT00606710
Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
An observational study of Ventricular Tachycardia, Ventricular Fibrillation and Heart Failure, run by Guidant Corporation at 4 sites in 2 countries.
Trial summary
The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure
- What is being tested?
- Cognis 100-D, Teligen DR, VR 100 HE
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2008to Oct 2008
- Phase
- Observational
- 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
Study population: Patients with risk of developing life threatening ventricular arrhythmias with and without heart failure
Who may be able to join
- ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
- CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
- Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
- Geographically stable patients who are available for follow-up at a study centre
- Age 18 or above, or of legal age to give informed consent specific to national law
Who cannot join
- Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- Patients currently requiring dialysis
- Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
- Enrolled in any concurrent study
- Patients implanted with the following leads which will not be abandoned:
- Atrial or right ventricular unipolar leads
- Patch defibrillation leads
- Non-compatible defibrillation leads (e.g. 5/6mm)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Israel3 sites
Barzilay Medical Center
Ashkelon, 78306
Tel Aviv Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer, 52621
About this study
The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.
- Being tested
- Cognis 100-D, Teligen DR, VR 100 HE
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognis 100-D, Teligen DR, VR 100 HEDevice
Also called Reliance Quadripolar Defibrillation Lead
ICD or CRT - Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate detection of ventricular arrhythmias
Measured: Predischarge
Secondary outcomes (1)
Appropriate shock conversion
Measured: Predischarge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia, Ventricular FibrillationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation
- Investigators
- Poul Erik Bloch Thomsen, MD, Principal investigator, KAS Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606710
- Sponsor's protocol ID
- Cogent-4 0806
- Acronym
- Cogent-4
- Status last verified
- Nov 2008
- First submitted
- 22 Jan 2008
- Last updated
- 24 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
- ClinicalTrials.gov ID
- NCT00606710
- Acronym / sponsor ID
- Cogent-4 / Cogent-4 0806
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Feb 2008 (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 COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with risk of developing life threatening ventricular arrhythmias with and without heart failure
Key inclusion criteria (5 listed)
- ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
- CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
- Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
- Geographically stable patients who are available for follow-up at a study centre
- Age 18 or above, or of legal age to give informed consent specific to national law
Key exclusion criteria (8 listed)
- Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- Patients currently requiring dialysis
- Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
- Enrolled in any concurrent study
- Patients implanted with the following leads which will not be abandoned:
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 |
|---|---|---|
| Cognis 100-D, Teligen DR, VR 100 HEAlso: Reliance Quadripolar Defibrillation LeadICD or CRT - Therapy | Device | – |
Primary outcome
Appropriate detection of ventricular arrhythmias
Time frame: Predischarge
1 secondary outcome
Appropriate shock conversion
Time frame: Predischarge
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 24 Nov 2008.
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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.
Poul Erik Bloch Thomsen, MD principal investigator
KAS Gentofte Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, Ventricular Fibrillation and Heart Failure, run by Guidant Corporation at 4 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 8 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 24 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, Denmark. 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?
Appropriate detection of ventricular arrhythmias (time frame: Predischarge). 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 24 Nov 2008.