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NCT01636804 · ClinicalTrials.gov registry record
Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads
A clinical trial, sponsored by Dhanunjaya Lakkireddy, MD, FACC.
- Completed
- Registry status
- 190
- Enrollment target
NCT01636804: Completed study, sponsored by Dhanunjaya Lakkireddy, MD, FACC.
NCT01636804 is a clinical trial that has completed, run by Dhanunjaya Lakkireddy, MD, FACC. The registered enrollment target is 190 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01636804 has completed, sponsored by Dhanunjaya Lakkireddy, MD, FACC.
- COMPLETED
- Registry status
- 190 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Quicksite
- DEVICE Quickflex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2012-07 |
What the finished NCT01636804 record still lists
NCT01636804 is an observational study that tracks outcomes without assigning an intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Quicksite is the first listed.
NCT01636804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636804 about?
NCT01636804 is a clinical study titled "Incidence & Predictors of Mechanical Abnormalities of QuickSite® and QuickFlex® Left Ventricular Pacing Leads". 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...
What is the current status of trial NCT01636804?
This trial is currently completed. The enrollment target is 190 participants. The study started on 2012-07.
What interventions are being tested in trial NCT01636804?
The interventions under investigation include: Quicksite (DEVICE), Quickflex (DEVICE).
Who is sponsoring clinical trial NCT01636804?
This trial is sponsored by Dhanunjaya Lakkireddy, MD, FACC, which has 7 total clinical trials registered on ClinicalTrials.gov.
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