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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014