MedTrace Logo

CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

NCT00832988 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2019-02-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832988 on ClinicalTrials.gov