Transvenous Lead Removal Post-Market Clinical Study

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

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 Overview

• Status: Completed
• Conditions: Cardiac Electrophysiology
• Intervention / Treatment: Device: Cook lead extraction devices

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • German Heart Center Berlin
• Netherlands
  • Zwolle, Netherlands
    • Isala
• United Kingdom
  • London, United Kingdom, SW17 0QT
    • St. George's University Hospital
• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Medical Center
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Carle Foundation
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Reseach
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • WellSpan York Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring percutaneous removal of Cardiovascular Implantable Electronic Device (CIED) leads

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cook Research Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Defibrillators, Implantable; Cardiac pacing, artificial; Cardiac Resynchronizaton Therapy Devices
• Other Study ID Numbers: 16-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No