Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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

Official Title

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

Keywords

Cardiac Electrophysiology Cardiac pacing, artificial Cardiac Resynchronizaton Therapy Devices Defibrillators, Implantable Cook lead extraction devices

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • UCSF Medical Center not yet accepting patients
    San Francisco California 94143 United States
  • Memorial Hermann not yet accepting patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cook Research Incorporated
ID
NCT03688412
Study Type
Observational
Last Updated