CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

NCT00832988 | Completed DMC

• 1 other identifier: SJM LV001
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 6

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. 1.The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
2. 2.The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.

Conditions

Pacemaker

Keywords

pacing thresholds; sensing; impedance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Pacemaker patients

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

Other: VentricularAutoCaptureTM & ACapTM Confirm

Interventions

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.

Also known as: Zephyr™ pacemaker, VentricularAutoCaptureTM, ACapTM Confirm

Pacemaker patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary device clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

North Shore Heart Group

Vancouver, British Columbia, V7L2P7, Canada

Location

William Osler Health Centre

Brampton, Ontario, L6R 3J7, Canada

Location

Peterborough Regional

Peterborough, Ontario, Canada

Location

Clinique de Cardiologie Desilets

Québec, Quebec, G1J 1Z6, Canada

Location

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1R 2J6, Canada

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: October 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

CA (6)