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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00920452
First received: June 12, 2009
Last updated: December 3, 2012
Last verified: November 2010
  Purpose

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.


Condition
ICD and CRT-D Indicated Patients

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • Appropriate Detection of induced VT [ Time Frame: At Implant or during VT/VF testing up to one month after implant ] [ Designated as safety issue: Yes ]
    Induced mean VT/VF detection time < 4.5 seconds

  • Appropriate induced VT/VF Shock Conversion [ Time Frame: At Implant or during testing within one month after implant ] [ Designated as safety issue: Yes ]
    Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher

  • Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads [ Time Frame: entire duration of the study ] [ Designated as safety issue: Yes ]
    Mean pacing threshold post implant ≤ 1.5V

  • Appropriate Lead Impedances as a measure of lead integrity over 12 month time [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]
    • Shocking lead impedance should be within the range of 20 and 80 OHM
    • Pace /sense lead impedance within 200 and 2000 OHM

  • Appropriate sensing and absence of artefacts [ Time Frame: entire duration of study ] [ Designated as safety issue: Yes ]
    Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU


Enrollment: 430
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920452

Locations
Germany
Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, Nordrhein-Westfalen, Germany, D - 32545
Sponsors and Collaborators
Guidant Corporation
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00920452     History of Changes
Other Study ID Numbers: 4-SITE FF 0209
Study First Received: June 12, 2009
Last Updated: December 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Guidant Corporation:
implantable cardioverter defibrillator (ICD)
defibrillation leads, cardiac resynchronization therapy (CRT)

ClinicalTrials.gov processed this record on April 17, 2014