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

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ClinicalTrials.gov Identifier: NCT01636804
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute

Brief 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.


Condition or disease Intervention/treatment
Left Ventricular Pacing Leads Device: Quicksite Device: Quickflex

Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads: Impact on Electrophysiological Profile
Study Start Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol
U.S. FDA Resources

Group/Cohort Intervention/treatment
Quicksite and Quickflex
Patients who have received the leads affected by the medical product advisory
Device: Quicksite
St. Jude Medical produced lead called Quicksite
Device: Quickflex
St. Jude Medical produced lead called Quickflex



Primary Outcome Measures :
  1. Evaluate the mechanical/structural abnormalities in implanted St Jude Medical QuickSite® and QuickFlex® left ventricular (LV) pacing leads


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that received either Quicksite or Quickflex leads at the University of Kansas Hospital
Criteria

Inclusion Criteria:

  • Patient that received Quicksite or Quickflex lead at the University of Kansas Hospital

Exclusion Criteria:

  • Not willing to consent to data collection

Information from the National Library of Medicine

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): NCT01636804


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01636804     History of Changes
Other Study ID Numbers: 13211
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute:
Quicksite
Quickflex
St. Jude Medical

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents