Pacemaker and Defibrillator Lead Extraction Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lead Extraction Procedures. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Oregon Health & Science University Cardiac Implantable Electronic Device Extraction Registry
Overview
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.
Detailed description
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
Primary outcome measures
- safety (acute complications, per HRS consensus document) [Time frame: duration of hospitalization, typically 2 days to 2 weeks]
Eligibility criteria
Inclusion criteria
\- Undergoing lead extraction
Exclusion criteria
- registry--n/a
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Charles Henrikson — Portland
Identifiers
NCT: NCT03847025 · ER-9722