Clinical Trials Directory

Trials / Completed

CompletedNCT00606710

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

Status
Completed
Phase
—
Study type
Observational
Enrollment
450 (estimated)
Sponsor
Guidant Corporation · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICECognis 100-D, Teligen DR, VR 100 HEICD or CRT - Therapy

Timeline

Start date
2008-02-01
Primary completion
2008-10-01
Completion
2008-10-01
First posted
2008-02-04
Last updated
2008-11-24

Locations

4 sites across 2 countries: Denmark, Israel

Source: ClinicalTrials.gov record NCT00606710. Inclusion in this directory is not an endorsement.