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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker patients | Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VentricularAutoCaptureTM & ACapTM Confirm | Other | The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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primary device clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelowna General Hospital | Kelowna | British Columbia | Canada | |||
| North Shore Heart Group |
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|
| Vancouver |
| British Columbia |
| V7L2P7 |
| Canada |
| William Osler Health Centre | Brampton | Ontario | L6R 3J7 | Canada |
| Peterborough Regional | Peterborough | Ontario | Canada |
| Clinique de Cardiologie Desilets | Québec | Quebec | G1J 1Z6 | Canada |
| Centre Hospitalier Universitaire de Québec | Québec | Quebec | G1R 2J6 | Canada |