Transvenous Lead Removal Post-Market Clinical Study

Completed

• Conditions: Cardiac Electrophysiology
• Interventions: Device: Cook lead extraction devices

• Registration Number: NCT03688412
• Lead Sponsor: Cook Research Incorporated

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Study Start: 2018-10-18
• Primary Completion: 2020-01-28
• Status Verified: 2020-05
• Study Completion: 2020-05-11
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cook lead extraction devices	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.

Primary Outcome Measures

Name	Time	Method
Rate of clinical procedural success	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.
Rate of complete procedural success	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.

Trial Locations

Locations (9)

UCSF Medical Center; 🇺🇸 San Francisco, California, United States

Wellspan York Hospital; 🇺🇸 York, Pennsylvania, United States

University of VA Medical Center; 🇺🇸 Charlottesville, Virginia, United States

Carle Foundation; 🇺🇸 Urbana, Illinois, United States

Memorial Hermann; 🇺🇸 Houston, Texas, United States

Isala; 🇳🇱 Zwolle, Netherlands

NC Heart and Vascular Reseach; 🇺🇸 Raleigh, North Carolina, United States

St. George's University Hospital; 🇬🇧 London, United Kingdom

German Heart Center Berlin; 🇩🇪 Berlin, Germany