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

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

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.

Study Overview

• Status: Completed
• Conditions: ICD and CRT-D Indicated Patients

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)

• Study Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bad Oeynhausen, Nordrhein-Westfalen, Germany, D - 32545
      • Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study Population: Patients should be selected from the investigator's general population indicated for an ICD or CRT-D Implantation. The investigator has the responsibility of screening all potential patients and selecting those who meet study eligibility criteria.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate Detection of induced VT	Induced mean VT/VF detection time < 4.5 seconds	At Implant or during VT/VF testing up to one month after implant
Appropriate induced VT/VF Shock Conversion	Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher	At Implant or during testing within one month after implant
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads	Mean pacing threshold post implant ≤ 1.5V	entire duration of the study
Appropriate Lead Impedances as a measure of lead integrity over 12 month time	Shocking lead impedance should be within the range of 20 and 80 OHM; Pace /sense lead impedance within 200 and 2000 OHM	entire study duration
Appropriate sensing and absence of artefacts	Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU	entire duration of study

Collaborators and Investigators

• Sponsor: Guidant Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: implantable cardioverter defibrillator (ICD); defibrillation leads, cardiac resynchronization therapy (CRT)
• Other Study ID Numbers: 4-SITE FF 0209