Lead Extraction ProceduresNCT03847025
Pacemaker and Defibrillator Lead Extraction Registry
An observational study of Lead Extraction Procedures, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lead Extraction Procedures
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing clinically indicated lead extraction.
Who may be able to join
- Undergoing lead extraction
Who cannot join
- registry--n/a
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Charles Henrikson
Portland, Oregon, 97239
Charles Henrikson, MD, 503-494-7400, henrikso@ohsu.edu
Charles Henrikson, MD
About this study
Official title: The Oregon Health & Science University Cardiac Implantable Electronic Device 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 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.
Read the 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
- Keywords
- Pacemaker, Implantable cardioverter defibrillator, Lead extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lead extraction | Patients undergoing clinically indicated lead extraction procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety (acute complications, per HRS consensus document)
Primary outcome is safety of the lead extraction procedure, in terms of acute complications, per HRS consensus document.
Measured: duration of hospitalization, typically 2 days to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study startSep 2013
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead Extraction ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Henrikson, MD, Oregon Health and Science University
- Investigators
- Charles Henrikson, MD, Principal investigator, 503-494-0331
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847025
- Sponsor's protocol ID
- ER-9722
- Status last verified
- Apr 2024
- First submitted
- 25 Sep 2013
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oregon Health & Science University Cardiac Implantable Electronic Device Extraction Registry
- ClinicalTrials.gov ID
- NCT03847025
- Acronym / sponsor ID
- ER-9722
- Conditions
- Lead Extraction Procedures
- Keywords
- Pacemaker, Implantable cardioverter defibrillator, Lead extraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lead extraction | – | –Patients undergoing clinically indicated lead extraction procedures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing clinically indicated lead extraction.
Key inclusion criteria (1 listed)
- Undergoing lead extraction
Key exclusion criteria (1 listed)
- registry--n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
safety (acute complications, per HRS consensus document)
Time frame: duration of hospitalization, typically 2 days to 2 weeks
Primary outcome is safety of the lead extraction procedure, in terms of acute complications, per HRS consensus document.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Related trials for Lead Extraction Procedures
Not yet recruitingObservational study
Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.
Cardiac Implantable Electronic Device (CIED)
RecruitingObservational study
Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads
Infections, Pacemaker, Artificial
RecruitingObservational study
Japanese Lead Extraction Registry
Arrhythmia, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Henrikson, MD principal investigator
503-494-0331
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lead Extraction Procedures, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Henrikson, MD (503-494-0331, henrikso@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (acute complications, per HRS consensus document) (time frame: duration of hospitalization, typically 2 days to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.