CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

Completed

• Conditions: Pacemaker
• Interventions: Other: VentricularAutoCaptureTM & ACapTM Confirm

• Registration Number: NCT00832988
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pacemaker patients	VentricularAutoCaptureTM & ACapTM Confirm	Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (6)

Kelowna General Hospital; 🇨🇦 Kelowna, British Columbia, Canada

William Osler Health Centre; 🇨🇦 Brampton, Ontario, Canada

Peterborough Regional; 🇨🇦 Peterborough, Ontario, Canada

Clinique de Cardiologie Desilets; 🇨🇦 Québec, Quebec, Canada

Centre Hospitalier Universitaire de Québec; 🇨🇦 Québec, Quebec, Canada

North Shore Heart Group; 🇨🇦 Vancouver, British Columbia, Canada