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

NCT00606710 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2008-11-24

No results posted yet for this study

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.

Conditions

  • Ventricular Tachycardia, Ventricular Fibrillation
  • Heart Failure

Interventions

DEVICE

Cognis 100-D, Teligen DR, VR 100 HE

ICD or CRT - Therapy

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Guidant Corporation

    lead INDUSTRY

Principal Investigators

  • Poul Erik Bloch Thomsen, MD · KAS Gentofte Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Denmark
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606710 on ClinicalTrials.gov