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Pacemaker and Defibrillator Lead Extraction Registry

NCT03847025 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-04-15

No results posted yet for this study

Summary

Implanted cardiac devices are commonly used to treat a wide variety of heart diseases, including arrhythmias, cardiac resynchronization in select heart failure patients, and life threatening heart rhythms. Approximately 400,000 devices are implanted annually, and more than 3 million patients currently have implanted devices1.

Implanted cardiac devices are made to 2 components, the can and the leads. The can contains the electric circuits and the battery, which must be replaced every 5-10 years. The can is connected to external leads which pass through the subclavian vein, and depending on the device, into the vena cava, right atrium, right ventricle, and/or coronary sinus. Leads typically last longer than the battery, and are simply reconnected to a new can at the time of replacement.

Certain clinical situations necessitate lead removal, including pocket infection, device related endocarditis, venous stenosis or occlusion with the need for new access, and removal of abandoned or malfunctioning leads. Removing the leads is technically difficult due to fibrosis, and requires specialized equipment. Compared to lead implantation, extraction of leads is relatively rare, with a life time risk of a device patient needing an extraction in the 1-5% range. Given that this is a relatively rare procedure and is only done at a few centers, documentation of our experiences with lead extraction can lead to ongoing improvements in both procedural techniques and outcomes.

Conditions

  • Lead Extraction Procedures

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Charles Henrikson, MD · 503-494-0331

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847025 on ClinicalTrials.gov