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Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads

NCT01636804 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2013-08-09

No results posted yet for this study

Summary

On April 2, 2012 the manufacturer of the Quicksite® and Quickflex® leads, St. Jude Medical, released a voluntary medical device advisory regarding these leads' potential for problems with the silicone insulation covering one end of the lead, where it meets another section of the lead which is coated with a different insulating material (polyurethane). There has been a voluntary suspension of sales of these leads.

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.

Conditions

  • Left Ventricular Pacing Leads

Interventions

DEVICE

Quicksite

St. Jude Medical produced lead called Quicksite

DEVICE

Quickflex

St. Jude Medical produced lead called Quickflex

Sponsors & Collaborators

  • Dhanunjaya Lakkireddy, MD, FACC

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · University of Kansas Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636804 on ClinicalTrials.gov