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

NCT ID: NCT00606710

Last Updated: 2008-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Tachycardia, Ventricular Fibrillation Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cognis 100-D, Teligen DR, VR 100 HE

ICD or CRT - Therapy

Intervention Type DEVICE

Other Intervention Names

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Reliance Quadripolar Defibrillation Lead

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role lead

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Boston Scientific

Principal Investigators

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Poul Erik Bloch Thomsen, MD

Role: PRINCIPAL_INVESTIGATOR

KAS Gentofte Hospital

Locations

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KAS Gentofte Hospital

Hellerup, , Denmark

Site Status

Barzilay Medical Center

Ashkelon, , Israel

Site Status

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Denmark Israel

Other Identifiers

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Cogent-4 0806

Identifier Type: -

Identifier Source: org_study_id