- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00832988
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements (CONFIRM)
Comparison of in Office Interrogation vs. Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient; to compare the accuracy of the automated device test results to manual testing results; evaluate the percentage of patients who are recommended for ACapTM Confirm utilization.
The Primary Hypotheses are:
- The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
- The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Kelowna, British Columbia, Canada
- Kelowna General Hospital
-
Vancouver, British Columbia, Canada, V7L2P7
- North Shore Heart Group
-
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- William Osler Health Centre
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Peterborough, Ontario, Canada
- Peterborough Regional
-
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Quebec
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Québec, Quebec, Canada, G1J 1Z6
- Clinique de Cardiologie Desilets
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Québec, Quebec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients have been implanted with their device ~ 6 months prior
- Patients must have their device evaluated at the enrolling center.
- Patients must be able to comply with the regular routine follow-up schedule of the enrolling clinic.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
- Patients age 18 or greater.
Exclusion Criteria:
- Patient has a unipolar atrial lead implanted.
- Patients who are or may potentially be pregnant.
- Patients with persistent AF.
- Less than 1 year life expectancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Pacemaker patients
Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible
|
The testing algorithms allow the device to display threshold measurements at time of device interrogation.
These will be evaluated against manual testing results.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
Tidsramme: 12 and 18 months post-implant
|
12 and 18 months post-implant
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient.
Tidsramme: 12 and 18 months post-implant
|
12 and 18 months post-implant
|
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
Nøgleord
Andre undersøgelses-id-numre
- SJM LV001
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Kliniske forsøg med VentricularAutoCaptureTM & ACapTM Confirm
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Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Abbott Medical DevicesAfsluttetAtrieflimrenCanada, Holland
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University Hospital Inselspital, BerneAbbott; University Hospital, Zürich; Bangerter-Rhyner StiftungRekrutteringAtrieflimren | MINOCASchweiz