NCT00920452

The 4-SITE Field Following Study (4-SITE FF)

RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 430 (actual)
• Sponsor: Guidant Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE Quadripolar (4-SITE) defibrillation leads. Appropriate clinical performance of system components of the 4-SITE systems other than the new 4-SITE header / lead interface has been evaluated and documented already in the previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field Following Study. Data collected may be used to support international regulatory submissions including the FDA and the Japanese Ministry of Health, Labour and Welfare.

Detailed description

The following devices will be used (all are CE-marked): * TELIGEN 100 HE 4-SITE (Single and Dual Chamber ICD) * Model Number: F103 (Quadripolar, VR); * Model Number: F111 (Quadripolar, IS-1, DR) * COGNIS 100 HE 4-SITE (CRT-D) o Model Number: P108 (Quadripolar, IS-1, IS-1) * RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)

Conditions

• ICD and CRT-D Indicated Patients

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-06-15
• Last updated: 2012-12-05

Locations

1 site across 1 country: Germany