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Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following (Cogent-4)

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ClinicalTrials.gov Identifier: NCT00606710
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : November 24, 2008
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Guidant Corporation

Study Description
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Brief 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). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.

Condition or disease Intervention/treatment
Ventricular Tachycardia, Ventricular Fibrillation Heart Failure Device: Cognis 100-D, Teligen DR, VR 100 HE

Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
Study Start Date : February 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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Groups and Cohorts
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Intervention Details:
  • Device: Cognis 100-D, Teligen DR, VR 100 HE
    ICD or CRT - Therapy
    Other Name: Reliance Quadripolar Defibrillation Lead

Outcome Measures
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Primary Outcome Measures :
  1. Appropriate detection of ventricular arrhythmias [ Time Frame: Predischarge ]

Secondary Outcome Measures :
  1. Appropriate shock conversion [ Time Frame: Predischarge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with risk of developing life threatening ventricular arrhythmias with and without heart failure
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606710


Locations
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Denmark
KAS Gentofte Hospital
Hellerup, Denmark, 2900
Israel
Barzilay Medical Center
Ashkelon, Israel, 78306
Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Guidant Corporation
Boston Scientific Corporation
Investigators
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Principal Investigator: Poul Erik Bloch Thomsen, MD KAS Gentofte Hospital
More Information
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Responsible Party: Torsten Kayser, Boston Scientific
ClinicalTrials.gov Identifier: NCT00606710    
Other Study ID Numbers: Cogent-4 0806
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Heart Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes