CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Pacemaker

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Pacemaker patients

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

VentricularAutoCaptureTM & ACapTM Confirm

Intervention Type OTHER

The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Zephyr™ pacemaker VentricularAutoCaptureTM ACapTM Confirm

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No