Transvenous Lead Removal Post-Market Clinical Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03688412

Enrollment

230

Registered

2018-09-28

Start date

2018-10-18

Completion date

2020-05-11

Last updated

2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Electrophysiology

Keywords

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

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

Interventions

DEVICECook 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany, Netherlands, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026