Clinical trial NCT03847025: Pacemaker and Defibrillator Lead Extraction Registry
Official title: The Oregon Health & Science University Cardiac Implantable Electronic Device Extraction Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lead Extraction Procedures
Keywords: Pacemaker
Implantable cardioverter defibrillator
Lead extraction
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing clinically indicated lead extraction.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

- Undergoing lead extraction

Exclusion Criteria:

* registry--n/a

Primary outcomes:
measure: safety (acute complications, per HRS consensus document)
timeFrame: duration of hospitalization, typically 2 days to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Charles Henrikson
state: Oregon
Study officials:
affiliation: 503-494-0331
name: Charles Henrikson, MD
role: PRINCIPAL_INVESTIGATOR
References: