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- Essai clinique NCT00920452
The 4-SITE Field Following Study (4-SITE FF) (4-SITE FF)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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)
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Nordrhein-Westfalen
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Bad Oeynhausen, Nordrhein-Westfalen, Allemagne, D - 32545
- Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Appropriate Detection of induced VT
Délai: At Implant or during VT/VF testing up to one month after implant
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Induced mean VT/VF detection time < 4.5 seconds
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At Implant or during VT/VF testing up to one month after implant
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Appropriate induced VT/VF Shock Conversion
Délai: At Implant or during testing within one month after implant
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Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher
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At Implant or during testing within one month after implant
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Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads
Délai: entire duration of the study
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Mean pacing threshold post implant ≤ 1.5V
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entire duration of the study
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Appropriate Lead Impedances as a measure of lead integrity over 12 month time
Délai: entire study duration
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entire study duration
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Appropriate sensing and absence of artefacts
Délai: entire duration of study
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Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
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entire duration of study
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 4-SITE FF 0209
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur ICD and CRT-D Indicated Patients
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Abbott Medical DevicesComplétéLe patient respecte les directives ACC/AHA/ESC pour le défibrillateur automatique implantable (ICD) ou le dispositif de thérapie de resynchronisation cardiaque (CRT-D)Royaume-Uni, Allemagne
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Tel-Aviv Sourasky Medical CenterComplétéSurveillance à domicile avec patient ICDIsraël
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Hartford HospitalInconnueImplanté avec n'importe quel appareil Medtronic ICD ou CRT actuellement (et à l'avenir) approuvé par la FDA | auquel est attaché un plomb St. Jude RiataÉtats-Unis