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

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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


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
San Francisco, California 94115
Phone: 415-476-7061
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Berlin,
Phone: +49 30 45931000
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Berlin,
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Charlottesville, Virginia
Phone: 434-243-1000
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Charlottesville, VA
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Houston, Texas 77030
Phone: 713-704-4000
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Houston, TX
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Raleigh, North Carolina 27607
Phone: 919-784-3100
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Raleigh, NC
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Urbana, Illinois 61801
Phone: 217-904-7155
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Urbana, IL
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York, Pennsylvania 17403
Phone: 717-851-2441
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York, PA
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