NCT00832988

CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

Comparison of in Office Interrogation vs. Remote Measurements

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pacemaker

Interventions

Type	Name	Description
OTHER	VentricularAutoCaptureTM & 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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-01-30
• Last updated: 2019-02-04

Locations

6 sites across 1 country: Canada