This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations
Study Type
OBSERVATIONAL
Enrollment
230
The Cook lead extraction devices are mechanical devices that encompass a full variety of devices required for percutaneous removal of CIED leads, indwelling catheters and foreign objects.
UCSF Medical Center
San Francisco, California, United States
Carle Foundation
Urbana, Illinois, United States
NC Heart and Vascular Reseach
Raleigh, North Carolina, United States
Wellspan York Hospital
York, Pennsylvania, United States
Rate of complete procedural success
Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death.
Time frame: Immediately following lead extraction
Rate of clinical procedural success
Clinical procedural success is the removal of all targeted leads and all lead material from the vascular space, or retention of a small portion of the lead (fragment that is 4 cm or smaller) that does not negatively impact the outcome goals of the procedure.
Time frame: Immediately following lead extraction
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Memorial Hermann
Houston, Texas, United States
University of VA Medical Center
Charlottesville, Virginia, United States
German Heart Center Berlin
Berlin, Germany
Isala
Zwolle, Netherlands
St. George's University Hospital
London, United Kingdom