Transvenous Lead Removal Post-Market Clinical Study

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT03688412

Collaborator

(none)

230

Enrollment

Locations

18.8

Actual Duration (Months)

25.6

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Electrophysiology	Device: Cook lead extraction devices

Study Design

Study Type:

Observational

Actual Enrollment :

230 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 18, 2018

Actual Primary Completion Date :

Jan 28, 2020

Actual Study Completion Date :

May 11, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Medical Center	San Francisco	California	United States	94143
2	Carle Foundation	Urbana	Illinois	United States	61801
3	NC Heart and Vascular Reseach	Raleigh	North Carolina	United States	27607
4	Wellspan York Hospital	York	Pennsylvania	United States	17403
5	Memorial Hermann	Houston	Texas	United States	77030
6	University of VA Medical Center	Charlottesville	Virginia	United States	22908
7	German Heart Center Berlin	Berlin		Germany
8	Isala	Zwolle		Netherlands
9	St. George's University Hospital	London		United Kingdom	SW17 0QT

Sponsors and Collaborators

Cook Research Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cook Research Incorporated

ClinicalTrials.gov Identifier:

NCT03688412

Other Study ID Numbers:

16-04

First Posted:

Sep 28, 2018

Last Update Posted:

May 28, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cook Research Incorporated

Cardiac pacing, artificial

Cardiac Resynchronizaton Therapy Devices

Defibrillators, Implantable

Study Results

No Results Posted as of May 28, 2020