Pacemaker and Defibrillator Lead Extraction Registry

Conditions

• Lead Extraction Procedures

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Sep 30, 2013

Status verified

Apr 2024

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: 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

• Charles Henrikson, MD
  503-494-0331
  [email protected]

Locations (1)

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