Cardiac Surgical ProceduresEXTRACTNCT01169441
Lead Extract Study
An observational study of Cardiac Surgical Procedures, run by St. Paul Heart Clinic at 1 site in United States.
Trial summary
The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted. Younger and healthier patients are now being implanted for primary prevention of sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are scheduled for an ICD lead extraction
Who may be able to join
- Subjects must be 18 years of age or older,
- be scheduled for an ICD lead extraction and
- willing and able to sign the informed consent.
Who cannot join
- Patients with lead implant duration less than 6 months,
- patients with gross chronic lead infections,
- patients with epicardial or subcutaneous ICD systems (without transvenous ICD lead) and
- patients who are pregnant or suspect they may be pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXTRACT Study (Data Collection on the Extraction of 2nd and 3rd Generation Defibrillation Leads)
The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted. Younger and healthier patients are now being implanted for primary prevention of sudden cardiac death. Due to the younger population, the likelihood of the lead failing during the lifetime of the patient is higher and also more likely to need extraction. To reduce the risk of the lead extraction procedure and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads to offer improved chronic extractability to reduce the morbidity and mortality during these procedures.
Read the detailed description
This study will enroll up to 100 subjects at our site only. Prior to the procedure information will be collected including the subjects demographics, medications, medical, cardiovascular and surgical history. During the lead extraction procedure specific data will be gathered which includes items such as: total lead length, lead length from insertion site to connector end of lead just prior to lead extraction, extraction tools used and the physician description of the extraction. The patients will undergo an assessment of extraction force up to 3 kilograms maximum to the ICD lead for a specified amount of time before the use of laser or extraction sheaths. Extraction forces and approximate times will be monitored and recorded throughout the procedure. Forces will be measured by using a force gauge. Xrays will be taken to show lead position during movement of the arm at the side, above the head and across the chest. Fluoroscopy images of the heart may be saved. The amount of extra time added to the case in order to perform this study and collect the data is estimated at 10 minutes. Participation in the study is complete following the procedure. There is a 30-day follow-up phone call to capture any adverse events which require a clinic visit, ER visit or hospitalization.
- Conditions
- Cardiac Surgical Procedures
- Keywords
- ICD leads, Removal, Extraction, Ventricular leads, Extract, laser, Observe the lead with x-ray during movement and collect information on current ways of removing an ICD lead.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startNov 2006
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical 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
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul Heart Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Pierce J. Vatterott, M.D., Principal investigator, St. Paul Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169441
- Sponsor's protocol ID
- #2265-4
- Acronym
- EXTRACT
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXTRACT Study (Data Collection on the Extraction of 2nd and 3rd Generation Defibrillation Leads)
- ClinicalTrials.gov ID
- NCT01169441
- Acronym / sponsor ID
- EXTRACT / #2265-4
- Conditions
- Cardiac Surgical Procedures
- Keywords
- ICD leads, Removal, Extraction, Ventricular leads, Extract, laser, Observe the lead with x-ray during movement and collect information on current ways of removing an ICD lead.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Paul Heart ClinicUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Jul 2010 (estimated)
- 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.
The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted. Younger and healthier patients are now being implanted for primary prevention of sudden cardiac death. Due to the younger population, the likelihood of the lead failing during the lifetime of the patient is higher and also more likely to need extraction. To reduce the risk of the lead extraction procedure and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads to offer improved chronic extractability to reduce the morbidity and mortality during these procedures.
Detailed description
This study will enroll up to 100 subjects at our site only. Prior to the procedure information will be collected including the subjects demographics, medications, medical, cardiovascular and surgical history. During the lead extraction procedure specific data will be gathered which includes items such as: total lead length, lead length from insertion site to connector end of lead just prior to lead extraction, extraction tools used and the physician description of the extraction. The patients will undergo an assessment of extraction force up to 3 kilograms maximum to the ICD lead for a specified amount of time before the use of laser or extraction sheaths. Extraction forces and approximate times will be monitored and recorded throughout the procedure. Forces will be measured by using a force gauge. Xrays will be taken to show lead position during movement of the arm at the side, above the head and across the chest. Fluoroscopy images of the heart may be saved. The amount of extra time added to the case in order to perform this study and collect the data is estimated at 10 minutes. Participation in the study is complete following the procedure. There is a 30-day follow-up phone call to capture any adverse events which require a clinic visit, ER visit or hospitalization.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are scheduled for an ICD lead extraction
Key inclusion criteria (3 listed)
- Subjects must be 18 years of age or older,
- be scheduled for an ICD lead extraction and
- willing and able to sign the informed consent.
Key exclusion criteria (4 listed)
- Patients with lead implant duration less than 6 months,
- patients with gross chronic lead infections,
- patients with epicardial or subcutaneous ICD systems (without transvenous ICD lead) and
- patients who are pregnant or suspect they may be pregnant.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
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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. This study is not recruiting at the moment.
Pierce J. Vatterott, M.D. principal investigator
St. Paul Heart Clinic
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 Cardiac Surgical Procedures, run by St. Paul Heart Clinic 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jul 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 26 Jul 2010.