CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

Pacemaker Clinical Trial

— CONFIRM  

Official title:

Comparison of in Office Interrogation vs. Remote Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832988
• Other study ID #: SJM LV001
• Status: Completed
• Start date: October 2008
• Est. completion date: February 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker

Intervention

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.

Locations

Country	Name	City	State
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	Peterborough Regional	Peterborough	Ontario
Canada	Centre Hospitalier Universitaire de Québec	Québec	Quebec
Canada	Clinique de Cardiologie Desilets	Québec	Quebec
Canada	North Shore Heart Group	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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