Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

3. desember 2012 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

ICD and CRT-D Indicated Patients

Detaljert beskrivelse

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)

Studietype

Observasjonsmessig

Registrering (Faktiske)

430

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Appropriate Detection of induced VT Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: entire duration of study	Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU	entire duration of study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Guidant Corporation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2009

Primær fullføring (Faktiske)

1. januar 2011

Studiet fullført (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først innsendt

12. juni 2009

Først innsendt som oppfylte QC-kriteriene