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Completed

NCT Number: NCT00920452

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.

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Key information

Conditions

ICD and CRT-D Indicated Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, D - 32545, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Appropriate Detection of induced VT

    Time frame: At Implant or during VT/VF testing up to one month after implant

    Induced mean VT/VF detection time < 4.5 seconds

  2. Appropriate induced VT/VF Shock Conversion

    Time frame: At Implant or during testing within one month after implant

    Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher

  3. Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads

    Time frame: entire duration of the study

    Mean pacing threshold post implant ≤ 1.5V

  4. Appropriate Lead Impedances as a measure of lead integrity over 12 month time

    Time frame: entire study duration

    • Shocking lead impedance should be within the range of 20 and 80 OHM
    • Pace /sense lead impedance within 200 and 2000 OHM

  5. Appropriate sensing and absence of artefacts

    Time frame: entire duration of study

    Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU

Sponsors and collaborators

Lead sponsor

Guidant Corporation

Industry

Registry information

Official study title

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

Acronym: 4-SITE FF

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2009
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.