CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

Study Overview
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Brief Summary
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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: 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.

Official Title
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Comparison of in Office Interrogation vs. Remote Measurements

Conditions
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Pacemaker

Intervention / Treatment
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* Other: VentricularAutoCaptureTM & ACapTM Confirm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker patients<br>Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible | Other: VentricularAutoCaptureTM & ACapTM Confirm<br>* The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results.<br>* Other names: ACapTM Confirm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacing thresholds, sensing, impedance