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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 29, 2009
Last Updated Date	June 7, 2013
Start Date ^ICMJE	October 2008
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 29, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00832988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 29, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
Official Title ^ICMJE	Comparison of in Office Interrogation vs. Remote Measurements
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: 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Crossover Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	primary device clinic
Condition ^ICMJE	Pacemaker
Intervention ^ICMJE	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
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date	February 2013
Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00832988
Other Study ID Numbers ^ICMJE	SJM LV001
Has Data Monitoring Committee	Yes
Responsible Party	St. Jude Medical
Study Sponsor ^ICMJE	St. Jude Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	St. Jude Medical
Verification Date	June 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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