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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01636804
First received: July 5, 2012
Last updated: August 6, 2013
Last verified: August 2013
  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 University of Kansas:

Primary Outcome Measures:
  • Evaluate the mechanical/structural abnormalities in implanted St Jude Medical QuickSite® and QuickFlex® left ventricular (LV) pacing leads [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 5, 2012
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Quicksite
Quickflex
St. Jude Medical

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014