RELEASE:Transvenous Lead Removal Post-Market Clinical Study
Research type
Research Study
Full title
RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study
IRAS ID
254225
Contact name
Mark Gallagher
Contact email
Sponsor organisation
Cook Research Incorporated
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research 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.
This clinical study will enroll 230 patients at up to 10 clinical sites within the United States and Europe.
The primary endpoint of the clinical study is the rate of complete procedural success and rate of clinical procedural success. The primary hypothesis is to confirm the rate of clinical procedural success and the rate of complete procedural success in the clinical study against a performance goal of 87.7%.
The secondary endpoints assessed include:
• Major complications (See Appendix D for definitions), and
• Damage to a non-targeted lead (other than the lead intended to be removed).Additional measures will include:
• Use of the Cook Evolution® RL Controlled-Rotation Dilator Sheath as the first-line method during lead extraction procedure, and
• Procedural costs, which will include the collection of detailed UB-04 or CMS-1500 forms (US sites only).Anticipated Clinical Benefits: Transvenous lead removal using the Evolution® lead extraction system could result in resolving CIED-related medical concerns including device-related infection, lead malfunction or other indications requiring CIED intervention.
Patients are expected to participate in this clinical study for approximately 4 weeks (one study follow-up visit) after discharge from the lead extraction (removal) procedure.
REC name
HSC REC B
REC reference
19/NI/0080
Date of REC Opinion
5 Jun 2019
REC opinion
Further Information Favourable Opinion