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

3 december 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

ICD and CRT-D Indicated Patients

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

430

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Appropriate Detection of induced VT Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: entire duration of study	Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU	entire duration of study

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Guidant Corporation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2009

Primaire voltooiing (Werkelijk)

1 januari 2011

Studie voltooiing (Werkelijk)

1 januari 2011

Studieregistratiedata

Eerst ingediend

12 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria