Transvenous Lead Removal Post-Market Clinical Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | October 18, 2018 |
| End Date: | May 2020 |
| Contact: | Brenda Johnson, MS, RVT |
| Email: | brenda.johnson@cookmedical.com |
| Phone: | 765-463-7537 |
RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.
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
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
Inclusion Criteria:
1. Patients must be 18 years of age or older
2. Lead indwell time greater than 1 year
Exclusion Criteria:
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
We found this trial at
7
sites
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