CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00832988
First received: January 29, 2009
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention
Pacemaker
Other: VentricularAutoCaptureTM & ACapTM Confirm

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Comparison of in Office Interrogation vs. Remote Measurements

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: October 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pacemaker patients
Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible
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.
Other Names:
  • Zephyr™ pacemaker
  • VentricularAutoCaptureTM
  • ACapTM Confirm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary device clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832988

Locations
Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada
North Shore Heart Group
Vancouver, British Columbia, Canada, V7L2P7
Canada, Ontario
William Osler Health Centre
Brampton, Ontario, Canada, L6R 3J7
Peterborough Regional
Peterborough, Ontario, Canada
Canada, Quebec
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1R 2J6
Clinique de Cardiologie Desilets
Québec, Quebec, Canada, G1J 1Z6
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00832988     History of Changes
Other Study ID Numbers: SJM LV001
Study First Received: January 29, 2009
Last Updated: June 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Jude Medical:
pacing thresholds
sensing
impedance

ClinicalTrials.gov processed this record on April 20, 2014