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

November 21, 2008 updated by: Guidant Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Cognis 100-D, Teligen DR, VR 100 HE

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Hellerup, Denmark, 2900
    - KAS Gentofte Hospital
Israel
- - Ashkelon, Israel, 78306
    - Barzilay Medical Center
  - Tel Aviv, Israel, 64239
    - Tel Aviv Medical Center
  - Tel Hashomer, Israel, 52621
    - Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with risk of developing life threatening ventricular arrhythmias with and without heart failure

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Appropriate detection of ventricular arrhythmias Time Frame: Predischarge	Predischarge

Secondary Outcome Measures

Outcome Measure	Time Frame
Appropriate shock conversion Time Frame: Predischarge	Predischarge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guidant Corporation

Collaborators

Boston Scientific Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)