Transvenous Lead Removal Post-Market Clinical Study

Cook Group

Status: Completed

Conditions: Cardiac Electrophysiology

Treatments: Device: Cook lead extraction devices

Study type: Observational

Funder types: Industry

Identifiers

NCT03688412

16-04

Details and patient eligibility

About

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

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

230 participants in 1 patient group

Cook lead extraction devices

Description:

The Cook lead extraction devices are indicated for use in patients requiring percutaneous removal of CIED leads, indwelling catheters and foreign objects.

Treatment:

Device: Cook lead extraction devices