Transvenous Lead Removal Post-Market Clinical Study
NCT03688412 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230
Last updated 2020-05-28
Summary
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
Conditions
- Cardiac Electrophysiology
Interventions
- 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.
Sponsors & Collaborators
-
Cook Research Incorporated
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-10-18
- Primary Completion
- 2020-01-28
- Completion
- 2020-05-11
Countries
- United States
- Germany
- Netherlands
- United Kingdom
Study Locations
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