Transvenous Lead Removal Post-Market Clinical Study

Cardiac Electrophysiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688412
• Other study ID #: 16-04
• Status: Completed
• Start date: October 18, 2018
• Est. completion date: May 11, 2020

Study information

• Verified date: May 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 11, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Electrophysiology

Intervention

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.

Locations

Country	Name	City	State
Germany	German Heart Center Berlin	Berlin
Netherlands	Isala	Zwolle
United Kingdom	St. George's University Hospital	London
United States	University of VA Medical Center	Charlottesville	Virginia
United States	Memorial Hermann	Houston	Texas
United States	NC Heart and Vascular Reseach	Raleigh	North Carolina
United States	UCSF Medical Center	San Francisco	California
United States	Carle Foundation	Urbana	Illinois
United States	Wellspan York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete procedural success	Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death.	Immediately following lead extraction
Primary	Rate of clinical procedural success	Clinical procedural success is the removal of all targeted leads and all lead material from the vascular space, or retention of a small portion of the lead (fragment that is 4 cm or smaller) that does not negatively impact the outcome goals of the procedure.	Immediately following lead extraction