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: 1. The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic. 2. The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
Study Type
OBSERVATIONAL
Enrollment
115
The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results.
Kelowna General Hospital
Kelowna, British Columbia, Canada
North Shore Heart Group
Vancouver, British Columbia, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Peterborough Regional
Peterborough, Ontario, Canada
Clinique de Cardiologie Desilets
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
Time frame: 12 and 18 months post-implant
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.
Time frame: 12 and 18 months post-implant
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