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

January 29, 2009
June 7, 2013
October 2008
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00832988 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
Comparison of in Office Interrogation vs. Remote Measurements

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.
Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

primary device clinic

Pacemaker
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
Pacemaker patients
Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible
Intervention: Other: VentricularAutoCaptureTM & ACapTM Confirm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00832988
SJM LV001
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP