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

3 december 2012 uppdaterad av: Guidant Corporation

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.

Studieöversikt

Status

Avslutad

Betingelser

ICD and CRT-D Indicated Patients

Detaljerad beskrivning

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)

Studietyp

Observationell

Inskrivning (Faktisk)

430

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Tyskland
- Nordrhein-Westfalen
  - Bad Oeynhausen, Nordrhein-Westfalen, Tyskland, D - 32545
    - Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Appropriate Detection of induced VT Tidsram: At Implant or during VT/VF testing up to one month after implant	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 Tidsram: 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	At Implant or during testing within one month after implant
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads Tidsram: entire duration of the study	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 Tidsram: 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	entire study duration
Appropriate sensing and absence of artefacts Tidsram: entire duration of study	Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU	entire duration of study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Guidant Corporation

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2009

Primärt slutförande (Faktisk)

1 januari 2011

Avslutad studie (Faktisk)

1 januari 2011

Studieregistreringsdatum

Först inskickad

12 juni 2009

Först inskickad som uppfyllde QC-kriterierna