RECRUITING

Pacemaker and Defibrillator Lead Extraction Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2013-09
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03847025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * registry--n/a

Contacts and Locations

Study Contact

Charles Henrikson, MD
CONTACT
503-494-0331
henrikso@ohsu.edu

Principal Investigator

Charles Henrikson, MD
PRINCIPAL_INVESTIGATOR
503-494-0331

Study Locations (Sites)

Charles Henrikson
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Charles Henrikson, MD, PRINCIPAL_INVESTIGATOR, 503-494-0331

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-09
Study Completion Date2027-09

Study Record Updates

Study Start Date2013-09
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Pacemaker
  • Implantable cardioverter defibrillator
  • Lead extraction

Additional Relevant MeSH Terms

  • Lead Extraction Procedures