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OpenTrials
Completed

NCT Number: NCT03688412

Transvenous Lead Removal 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

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Key information

Conditions

Cardiac Electrophysiology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

German Heart Center Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of complete procedural success

    Time frame: 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.

  2. Rate of clinical procedural success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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