CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements (CONFIRM)

February 1, 2019 updated by: Abbott Medical Devices

Comparison of in Office Interrogation vs. Remote Measurements

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna General Hospital
      • Vancouver, British Columbia, Canada, V7L2P7
        • North Shore Heart Group
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health Centre
      • Peterborough, Ontario, Canada
        • Peterborough Regional
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z6
        • Clinique de Cardiologie Desilets
      • Québec, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

primary device clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
Time Frame: 12 and 18 months post-implant
12 and 18 months post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 and 18 months post-implant
12 and 18 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SJM LV001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe