CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
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About
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.
Enrollment
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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
Trial design
115 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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