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

Completed

• Conditions: Ventricular Tachycardia, Ventricular Fibrillation; Heart Failure

• Registration Number: NCT00606710
• Lead Sponsor: Guidant Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study Start: 2008-02
• Study First Posted: 2008-02-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-21
• Last Update Posted: 2008-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appropriate detection of ventricular arrhythmias	Predischarge

Secondary Outcome Measures

Name	Time	Method
Appropriate shock conversion	Predischarge

Trial Locations

Locations (4)

KAS Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel

Barzilay Medical Center; 🇮🇱 Ashkelon, Israel