CONFIRM - Comparison of in Office Interrogation Versus 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.

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Key information

Conditions

Pacemaker

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kelowna General Hospital, Kelowna, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VentricularAutoCaptureTM & ACapTM Confirm

Other

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

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Comparison of in Office Interrogation vs. Remote Measurements

Acronym: CONFIRM

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Jan 30, 2009
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed