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Completed

NCT Number: NCT00606710

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

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.

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Key information

Conditions

Ventricular Tachycardia, Ventricular Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KAS Gentofte Hospital, Hellerup, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognis 100-D, Teligen DR, VR 100 HE

Device

ICD or CRT - Therapy

Other names: Reliance Quadripolar Defibrillation Lead

Primary outcomes

  1. Appropriate detection of ventricular arrhythmias

    Time frame: Predischarge

Secondary outcomes

  1. Appropriate shock conversion

    Time frame: Predischarge

Sponsors and collaborators

Lead sponsor

Guidant Corporation

Industry

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: Cogent-4

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 4, 2008
Registry last updated
Nov 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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