Transvenous Lead Removal Post-Market Clinical Study

Completed

Conditions studied: Cardiac Electrophysiology

In brief

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

Key facts

Study ID

NCT03688412

Run by

Cook Research Incorporated

People needed

230

Starts

2018-10-18

Expected to finish

2020-05-11

Last updated by the study team

2020-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients must be 18 years of age or older
• Lead indwell time greater than 1 year

You may not qualify if…

• Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study
• Patient presents with an extracardiac lead

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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