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

Heart Failure Clinical Trial

— Cogent-4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606710
• Other study ID #: Cogent-4 0806
• Status: Completed
• Phase: N/A
• First received: January 22, 2008
• Last updated: November 21, 2008
• Start date: February 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia, Ventricular Fibrillation

Intervention

Device:
• Cognis 100-D, Teligen DR, VR 100 HE
ICD or CRT - Therapy

Locations

Country	Name	City	State
Denmark	KAS Gentofte Hospital	Hellerup
Israel	Barzilay Medical Center	Ashkelon
Israel	Tel Aviv Medical Center	Tel Aviv
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Guidant Corporation	Boston Scientific Corporation

Countries where clinical trial is conducted

Denmark,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate detection of ventricular arrhythmias		Predischarge	No
Secondary	Appropriate shock conversion		Predischarge	No