Transvenous Lead Removal Post-Market Clinical Study

Overview

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

Full Title of Study: “RELEASE: Transvenous Lead Removal Using the Cook Evolution® Lead Extraction System Post-Market Clinical Study.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 28, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cook Research Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor

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