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CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00832988
Collaborator
(none)
115
Enrollment
6
Locations
52
Duration (Months)
19.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: VentricularAutoCaptureTM & ACapTM Confirm

Study Design

Study Type:
Observational
Actual Enrollment :
115 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Comparison of in Office Interrogation vs. Remote Measurements
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Pacemaker patients

Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible

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.
Other Names:
  • Zephyr™ pacemaker
  • VentricularAutoCaptureTM
  • ACapTM Confirm

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kelowna General Hospital Kelowna British Columbia Canada
    2 North Shore Heart Group Vancouver British Columbia Canada V7L2P7
    3 William Osler Health Centre Brampton Ontario Canada L6R 3J7
    4 Peterborough Regional Peterborough Ontario Canada
    5 Clinique de Cardiologie Desilets Québec Quebec Canada G1J 1Z6
    6 Centre Hospitalier Universitaire de Québec Québec Quebec Canada G1R 2J6

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00832988
    Other Study ID Numbers:
    • SJM LV001
    First Posted:
    Jan 30, 2009
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Abbott Medical Devices
    pacing thresholds
    sensing
    impedance

    Study Results

    No Results Posted as of Feb 4, 2019