Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00606710
First received: January 22, 2008
Last updated: November 21, 2008
Last verified: November 2008
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appropriate shock conversion [ Time Frame: Predischarge ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606710

Locations
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
Principal Investigator: Poul Erik Bloch Thomsen, MD KAS Gentofte Hospital
  More Information

No publications provided

Responsible Party: Torsten Kayser, Boston Scientific
ClinicalTrials.gov Identifier: NCT00606710     History of Changes
Other Study ID Numbers: Cogent-4 0806
Study First Received: January 22, 2008
Last Updated: November 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014