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

NCT01636804 | Completed

• 1 other identifier: 13211
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Pacing Leads

Keywords

Quicksite; Quickflex; St. Jude Medical

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Quicksite and Quickflex

Patients who have received the leads affected by the medical product advisory

Device: Quicksite; Device: Quickflex

Interventions

Quicksite DEVICE

St. Jude Medical produced lead called Quicksite

Quicksite and Quickflex

Quickflex DEVICE

St. Jude Medical produced lead called Quickflex

Quicksite and Quickflex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Not willing to consent to data collection

Sponsors & Collaborators

• Dhanunjaya Lakkireddy, MD, FACC: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

• Dhanunjaya Lakkireddy, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

US (1)