CompletedNot Applicable

Transvenous Lead Removal Post-Market Clinical Study

United States230 participantsStarted 2018-10-18

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Rate of complete procedural success

Timeframe: Immediately following lead extraction

Rate of clinical procedural success

Timeframe: Immediately following lead extraction

Trial details

NCT IDNCT03688412

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-01-28

View on ClinicalTrials.gov More Cardiac Electrophysiology trials