Pacemaker
Conditions
Keywords
pacing thresholds, sensing, impedance
Brief summary
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.
Interventions
OTHERVentricularAutoCaptureTM & ACapTM Confirm
The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results.
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds | 12 and 18 months post-implant |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 12 and 18 months post-implant |
Countries
Canada
Outcome results
None listed