Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads
NCT ID: NCT01636804
Last Updated: 2013-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
190 participants
OBSERVATIONAL
2012-07-31
Brief Summary
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There are approximately 179,000 of the above leads implanted worldwide with an estimated 101,000 leads currently in service (59,000 in US). There have been 39 confirmed cases of the conductor portion of the lead becoming exposed from the silicone insulation (externalization), and the rate of occurrence of this type of problem is conservatively estimated at less than one percent. However, a review done by St. Jude Medical of returned Quicksite® and Quickflex® leads and available X-ray and fluoroscopic (x-ray movie) images of patients with these leads (from 1,219 patients) revealed a higher rate of 3-4%. It is presumed that there are patients whose leads have not yet been affected by this problem, but whose leads may show signs of structural changes on x-ray or fluoroscopy. This study seeks to determine what structural changes may be occurring in these leads, what signs might predict these changes, and what impact these changes may have on the lead and its performance.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Quicksite and Quickflex
Patients who have received the leads affected by the medical product advisory
Quicksite
St. Jude Medical produced lead called Quicksite
Quickflex
St. Jude Medical produced lead called Quickflex
Interventions
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Quicksite
St. Jude Medical produced lead called Quicksite
Quickflex
St. Jude Medical produced lead called Quickflex
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Dhanunjaya Lakkireddy, MD, FACC
OTHER
Responsible Party
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Dhanunjaya Lakkireddy, MD, FACC
Associate Professor
Principal Investigators
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Dhanunjaya Lakkireddy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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13211
Identifier Type: -
Identifier Source: org_study_id