Transvenous Lead Removal Post-Market Clinical Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03688412|
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment|
|Cardiac Electrophysiology||Device: Cook lead extraction devices|
|Study Type :||Observational|
|Actual Enrollment :||230 participants|
|Official Title:||RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.|
|Actual Study Start Date :||October 18, 2018|
|Actual Primary Completion Date :||January 28, 2020|
|Actual Study Completion Date :||May 11, 2020|
Cook lead extraction devices
The Cook lead extraction devices are indicated for use in patients requiring percutaneous removal of CIED leads, indwelling catheters and foreign objects.
Device: Cook lead extraction devices
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.
- Rate of complete procedural success [ Time Frame: Immediately following lead extraction ]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.
- Rate of clinical procedural success [ Time Frame: Immediately following lead extraction ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688412
|United States, California|
|UCSF Medical Center|
|San Francisco, California, United States, 94143|
|United States, Illinois|
|Urbana, Illinois, United States, 61801|
|United States, North Carolina|
|NC Heart and Vascular Reseach|
|Raleigh, North Carolina, United States, 27607|
|United States, Pennsylvania|
|Wellspan York Hospital|
|York, Pennsylvania, United States, 17403|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|University of VA Medical Center|
|Charlottesville, Virginia, United States, 22908|
|German Heart Center Berlin|
|St. George's University Hospital|
|London, United Kingdom, SW17 0QT|