CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements (CONFIRM)
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|ClinicalTrials.gov Identifier: NCT00832988|
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : June 10, 2013
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:
- The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
- The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
|Condition or disease||Intervention/treatment|
|Pacemaker||Other: VentricularAutoCaptureTM & ACapTM Confirm|
|Study Type :||Observational|
|Actual Enrollment :||115 participants|
|Official Title:||Comparison of in Office Interrogation vs. Remote Measurements|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
- 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 ]
- 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 ]
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
|Canada, British Columbia|
|Kelowna General Hospital|
|Kelowna, British Columbia, Canada|
|North Shore Heart Group|
|Vancouver, British Columbia, Canada, V7L2P7|
|William Osler Health Centre|
|Brampton, Ontario, Canada, L6R 3J7|
|Peterborough, Ontario, Canada|
|Clinique de Cardiologie Desilets|
|Québec, Quebec, Canada, G1J 1Z6|
|Centre Hospitalier Universitaire de Québec|
|Québec, Quebec, Canada, G1R 2J6|