Skip to main content
Clinical Trials/NCT03847025
NCT03847025
Recruiting
N/A

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

Oregon Health and Science University1 site in 1 country300 target enrollmentSeptember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lead Extraction Procedures
Sponsor
Oregon Health and Science University
Enrollment
300
Locations
1
Primary Endpoint
safety (acute complications, per HRS consensus document)
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2027
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charles Henrikson, MD

Associate Professor of Medicine

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Undergoing lead extraction

Exclusion Criteria

  • registry--n/a

Outcomes

Primary Outcomes

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 Sites (1)

Loading locations...

Similar Trials