NCT03688412

Transvenous Lead Removal Post-Market Clinical Study

RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-10-18
• Primary completion: 2020-01-28
• Completion: 2020-05-11
• First posted: 2018-09-28
• Last updated: 2020-05-28

Locations

9 sites across 4 countries: United States, Germany, Netherlands, United Kingdom