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NCT Number: NCT03847025

Pacemaker and Defibrillator Lead Extraction Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Charles Henrikson

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Charles Henrikson, MD

CONTACT

[email protected]

503-494-7400

Charles Henrikson, MD

PRINCIPAL_INVESTIGATOR

About this study

Study Procedures

This is a retrospective review of data on patient characteristics (such as age, gender, co-morbidities), procedure specifications and indications, and outcomes of lead extraction done at OHSU.

Patients who have undergone either pacemaker or defibrillator lead extraction will have their charts reviewed for the desired data, which will then be compiled into a database. All procedures will be part of routine clinical care.

Data Analysis:

This is an observational registry study; there are no primary or secondary outcomes. Data will be analyzed to determine patient and procedural characteristics, procedure indications, complications and outcomes

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing lead extraction

Exclusion criteria

  • registry--n/a

Treatment and study plan

Primary outcomes

  1. safety (acute complications, per HRS consensus document)

    Time frame: duration of hospitalization, typically 2 days to 2 weeks

    Primary outcome is safety of the lead extraction procedure, in terms of acute complications, per HRS consensus document.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Henrikson, MD

CONTACT

[email protected]

503-494-0331

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

The Oregon Health & Science University Cardiac Implantable Electronic Device Extraction Registry

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2019
Registry last updated
Apr 15, 2024

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.