Transvenous Lead Removal Post-Market Clinical Study

NCT03688412 | Completed

• 1 other identifier: 16-04
• Study Type: observational
• Target: 230
• Locations: 4 countries
• Sites: 9

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

Conditions

Cardiac Electrophysiology

Keywords

Cardiac pacing, artificial; Cardiac Resynchronizaton Therapy Devices; Defibrillators, Implantable

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Cook lead extraction devices DEVICE

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.

Cook lead extraction devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients must be 18 years of age or older
• Lead indwell time greater than 1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (9)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Carle Foundation

Urbana, Illinois, 61801, United States

Location

NC Heart and Vascular Reseach

Raleigh, North Carolina, 27607, United States

Location

Wellspan York Hospital

York, Pennsylvania, 17403, United States

Location

Memorial Hermann

Houston, Texas, 77030, United States

Location

University of VA Medical Center

Charlottesville, Virginia, 22908, United States

Location

German Heart Center Berlin

Berlin, Germany

Location

Isala

Zwolle, Netherlands

Location

St. George's University Hospital

London, SW17 0QT, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 18, 2018
• Primary Completion: January 28, 2020
• Study Completion: May 11, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

DE (1); US (6); NL (1); GB (1)