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

This study has been completed.
Boston Scientific Corporation
Information provided by:
Guidant Corporation Identifier:
First received: January 22, 2008
Last updated: November 21, 2008
Last verified: November 2008
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 Intervention
Ventricular Tachycardia, Ventricular Fibrillation
Heart Failure
Device: Cognis 100-D, Teligen DR, VR 100 HE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following

Resource links provided by NLM:

Further study details as provided by Guidant Corporation:

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

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

Estimated Enrollment: 450
Study Start Date: February 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cognis 100-D, Teligen DR, VR 100 HE
    ICD or CRT - Therapy
    Other Name: Reliance Quadripolar Defibrillation Lead

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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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Please refer to this study by its identifier: NCT00606710

KAS Gentofte Hospital
Hellerup, Denmark, 2900
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
Principal Investigator: Poul Erik Bloch Thomsen, MD KAS Gentofte Hospital
  More Information

Responsible Party: Torsten Kayser, Boston Scientific Identifier: NCT00606710     History of Changes
Other Study ID Numbers: Cogent-4 0806
Study First Received: January 22, 2008
Last Updated: November 21, 2008

Additional relevant MeSH terms:
Heart Failure
Tachycardia, Ventricular
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes processed this record on April 26, 2017