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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00606710

Acronym

Cogent-4

Enrollment

450

Registered

2008-02-04

Start date

2008-02-29

Completion date

2008-10-31

Last updated

2008-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ventricular Tachycardia, Ventricular Fibrillation

Brief 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.

Interventions

DEVICECognis 100-D, Teligen DR, VR 100 HE

ICD or CRT - Therapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Appropriate detection of ventricular arrhythmias	Predischarge

Secondary

Measure	Time frame
Appropriate shock conversion	Predischarge

Countries

Denmark, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026