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

Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads: Impact on Electrophysiological Profile

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.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Pacing Leads
• Intervention / Treatment: Device: Quicksite; Device: Quickflex

• Study Type: Observational
• Enrollment (Anticipated): 190

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that received either Quicksite or Quickflex leads at the University of Kansas Hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to consent to data collection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dhanunjaya Lakkireddy, MD, FACC

Study record dates

Study Major Dates

• Study Start: July 1, 2012

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Quicksite; Quickflex; St. Jude Medical
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 13211