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CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements — CONFIRM  

Pacemaker Clinical Trial

Official title:
Comparison of in Office Interrogation vs. Remote Measurements

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00832988
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date October 2008
Completion date February 2013
View Details
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