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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636804
First Posted: July 10, 2012
Last Update Posted: August 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
  Purpose

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 Intervention
Left Ventricular Pacing Leads Device: Quicksite Device: Quickflex

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute:

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

Estimated Enrollment: 190
Study Start Date: July 2012
Groups/Cohorts Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: July 5, 2012
First Posted: July 10, 2012
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