RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cook Research Incorporated
- Enrollment
- 230
- Locations
- 9
- Primary Endpoint
- Rate of clinical procedural success
Study Overview
Brief 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients must be 18 years of age or older
- •Lead indwell time greater than 1 year
Exclusion Criteria
- •Patient is unable or unwilling to provide informed consent (per the IRB/EC requirements) to participate in the clinical study
- •Patient presents with an extracardiac lead
Outcomes
Primary Outcomes
Rate of clinical procedural success
Time Frame: Immediately following lead extraction
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.
Rate of complete procedural success
Time Frame: Immediately following lead extraction
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.
Secondary Outcomes
No secondary outcomes reported