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

NCT ID: NCT00920452

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 430 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-01-31

Brief 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

Keywords

implantable cardioverter defibrillator (ICD); defibrillation leads, cardiac resynchronization therapy (CRT)

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Study Specific:

• ICD / CRT-D Indication according to normal clinical practice
• Patients receiving:
• a single or dual chamber 4-SITE compatible ICD
• or a 4-SITE compatible CRT-D
• one of the RELIANCE 4-SITE defibrillation leads
• Patients currently implanted with a pacemaker
• upgraded to a 4-SITE compatible ICD or CRT-D (4-SITE header)
• one of the RELIANCE 4-SITE defibrillation leads

General:

• Willing and capable of providing informed consent for
• undergoing a 4-SITE system 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

Study Specific:

• ICD and CRT-D Patients scheduled for a device replacement
• CRM Patients who have or who would need an lead adaptor
• All patients who have an active or non-active defibrillation lead other than 4-SITE

General:

• Not willing and not capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation (including VT/VF shock conversion) at an approved clinical investigational centre and at the intervals defined by this protocol
• Patients who were in NYHA Class IV during the last 3 month
• Patients with pre-existing diseases, which may confound study results
• Patients currently requiring dialysis,
• Cancer patients
• Patients with drug and/or alcohol abuse history
• Life expectancy < 12 months (or expected heart transplant within 12 months)
• Patients on a Heart Transplant List
• Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion.
• Enrolled in any other concurrent study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guidant Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

4-SITE FF 0209

Identifier Type: -

Identifier Source: org_study_id