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CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements (CONFIRM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832988
First Posted: January 30, 2009
Last Update Posted: June 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Clinique de Cardiologie Desilets
Québec, Quebec, Canada, G1J 1Z6
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00832988     History of Changes
Other Study ID Numbers: SJM LV001
First Submitted: January 29, 2009
First Posted: January 30, 2009
Last Update Posted: June 10, 2013
Last Verified: June 2013

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