- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01161589
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data (FACTS)
Studieoversigt
Status
Detaljeret beskrivelse
The FACTS S-ICD study is a data gathering study that takes place during the implant procedure of a standard T-ICD system. Patients undergoing a routine dual chamber, dual high voltage shocking coil T-ICD or CRT-D insertion or replacement will be connected to an external data recorder via sterile cables. Atrial and ventricular arrhythmias will be induced while multiple ECG views are simultaneously recorded from both intracardiac and surface vectors. These episodes will then be digitized to create the FACTS S-ICD arrhythmia library.
As both dedicated and integrated bipolar sensing configurations are currently utilized in the marketplace, data will be collected using both market available ICD sensing methods.
The FACTS S-ICD study will enroll a sufficient quantity of patients such that a minimum of 50 atrial and 50 ventricular arrhythmic episodes are collected via both dedicated and integrated ICD systems. S-ICD signals will be collected for all recorded episodes.
The T-ICD implant procedure will be completed as per normal hospital practice and no further patient dependent data gathering will be required past the implant surgery and point of surgery arrhythmia inductions.
INCLUSION CRITERIA
- Age 18 or above, or legal age to give consent specific to state and national law.
- Any patient undergoing a clinically indicated initial dual chamber T-ICD or CRT-D implantation. In addition, patients who require replacement of an existing dual chamber T-ICD or CRT-D system will be eligible for enrollment in the study.
- Patient will have a subcutaneous, left pectoral defibrillator implant.
EXCLUSION CRITERIA
- Patients unable or unwilling to provide informed consent.
- Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
- Patients in chronic atrial fibrillation who have not been in sinus rhythm within the last six months.
- Enrollment in a concurrent study, without Cameron Health's written approval, that may confound the results of this study.
- Women who are pregnant or who are trying to become pregnant Note: Women of child bearing potential must have a negative pregnancy test within 7 days prior to defibrillator implant.
- Patient requires left sub-muscular or right sided defibrillator implant
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
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Rotterdam, Holland, 3000 CA
- Erasmus Medical Centre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 18 or above, or legal age to give consent specific to state and national law.
- Any patient undergoing a clinically indicated initial dual chamber T-ICD or CRT-D implantation. In addition, patients who require replacement of an existing dual chamber T-ICD or CRT-D system will be eligible for enrollment in the study.
- Patient will have a subcutaneous, left pectoral defibrillator implant
Exclusion Criteria:
- Patients unable or unwilling to provide informed consent.
- Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
- Patients in chronic atrial fibrillation who have not been in sinus rhythm within the last six months.
- Enrollment in a concurrent study, without Cameron Health's written approval, that may confound the results of this study.
- Women who are pregnant or who are trying to become pregnant Note: Women of child bearing potential must have a negative pregnancy test within 7 days prior to defibrillator implant.
- Patient requires left sub-muscular or right sided defibrillator implant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Collection of simultaneous cardiac signals representing S-ICD and ICD sensing vectors
Tidsramme: 3 years
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This study will enroll a sufficient number of patients such that a minimum of 50 atrial and 50 ventricular arrhythmic episodes are collected by dedicated and integrated ICD systems and by the simulated S-ICD system
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FACTS S-ICD
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Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Henry Ford Health SystemTrukket tilbage
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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Occlutech International ABAfsluttetSecundum atrial septal defekter
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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz