Pacemaker and Defibrillator Lead Extraction Registry

NCT ID: NCT03847025

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2027-09-30

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

Conditions

Lead Extraction Procedures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lead extraction

Patients undergoing clinically indicated lead extraction procedures.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Undergoing lead extraction

Exclusion Criteria

• registry--n/a

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Charles Henrikson, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Henrikson, MD

Role: PRINCIPAL_INVESTIGATOR

503-494-0331

Locations

Charles Henrikson

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charles Henrikson, MD

Role: CONTACT

henrikso@ohsu.edu

503-494-0331

Facility Contacts

Charles Henrikson, MD

Role: primary

henrikso@ohsu.edu

503-494-7400

Other Identifiers

ER-9722

Identifier Type: -

Identifier Source: org_study_id