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NCT03847025 · ClinicalTrials.gov registry record
Pacemaker and Defibrillator Lead Extraction Registry
A clinical trial of Lead Extraction Procedures, sponsored by Oregon Health and Science University.
- Recruiting
- Registry status
- 300
- Enrollment target
- 1
- Study location
NCT03847025: Recruiting study of Lead Extraction Procedures, sponsored by Oregon Health and Science University.
NCT03847025 is a study of Lead Extraction Procedures that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 300 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847025, a study of Lead Extraction Procedures, is actively recruiting participants, sponsored by Oregon Health and Science University.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Study Locations (1)
Oregon
- Charles Henrikson - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-09 |
| Est. Completion | 2027-09 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03847025
The ClinicalTrials.gov registry entry for NCT03847025 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lead Extraction Procedures appearing as the primary indexed condition, and to 0 interventions.
NCT03847025 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.
Frequently Asked Questions
What is clinical trial NCT03847025 about?
NCT03847025 is a clinical study titled "Pacemaker and Defibrillator Lead Extraction Registry". 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 current...
What is the current status of trial NCT03847025?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2013-09. Estimated completion is 2027-09.
What conditions does trial NCT03847025 study?
This clinical trial studies the following conditions: Lead Extraction Procedures.
Who is sponsoring clinical trial NCT03847025?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03847025 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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