Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT03847025

Conditions

Lead Extraction Procedures

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lead Extraction Procedures

Study ID

NCT03847025

Start date

Sep, 2013

Status verified date

Apr, 2024

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- Undergoing lead extraction

Exclusion Criteria:

  • registry--n/a

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Lead extraction

Patients undergoing clinically indicated lead extraction procedures.

Primary outcome measure

  • safety (acute complications, per HRS consensus document) [ Time Frame: duration of hospitalization, typically 2 days to 2 weeks ]

Central Contacts and Locations

Central contacts

Charles Henrikson, MD

503-494-0331henrikso@ohsu.edu

Locations

Charles Henrikson

Recruiting

Portland, Oregon, United States, 97239

Contacts

Charles Henrikson, MD

503-494-7400henrikso@ohsu.edu

Principal Investigator:

Charles Henrikson, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Keywords

  • Pacemaker
  • Implantable cardioverter defibrillator
  • Lead extraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-15.