- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00890461
Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Reconstructing a 12-lead surface ECG from intracardiac EGM vectors of patients implanted with defibrillators can be of great value. It allows implantable devices that have thus far been used exclusively for arrhythmia detection and treatment, to be used for diagnostic purposes in similar ways as the ECG. The advantage of the reconstruction process is that it provides real-time continuous monitoring, which can be used for multiple purposes, including but not limited to:
- Ischemia detection
- Myocardial Infarction detection
- Electrolyte abnormalities detection
- Assessment of effect of medications
- Improved rhythm discrimination
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- UPMC Presbyterian
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- UPMC Shadyside
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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:
- Subjects must be at least 18 years of age.
- Subjects must be referred for ICD implantation or already have an ICD implanted..
- Subjects must be willing to sign informed consent.
Exclusion Criteria:
- Subject is unable or unwilling to sign informed consent.
- Subject is pacemaker dependent.
- Subject is pregnant as indicated by standard clinical procedures prior to implant.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Defibrillator
The subject population will be obtained by approaching the Principal and Co- Investigators' patients who have been referred for ICD implantation or who already have an ICD.
This population ranges in age from 18 years on, and includes both males and females.
A maximum of 50 subjects will be enrolled in this study.
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Patients consenting to participate in the study may also undergo a baseline CT scan of the cest without contrast to allow for the geometrical characterization of their intracardiac electrodes from the ICD system in relation to the position of the 12-lead surface ECG electrodes which would be applied to the chest prior to the CT scan.
This scan involves a small amount of radiation, a dose of approximately 1 rem.
For comparison, radiation workers are permitted, by federal regulation, a maximum annual radiation exposure of 20 rems to the most sensitive organs of their body.
Andre navne:
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Samir F Saba, MD, University of Pittsburgh
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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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