Implant Site InfectionNCT02996929
Safety and Performance of LeadExx LC System in Lead Extraction
A study testing LC System in people with Implant Site Infection, run by LeadExx Cardiac Ltd..
Trial summary
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System and its ability to safely extract leads. The study will enroll 10 patients scheduled for CIED lead extraction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Implant Site Infection
- What is being tested?
- LC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Apr 2017
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-75 years old.
- Scheduled for an CIED lead extraction upon current guidelines
- Willing and able to sign the informed consent.
- Lead implant duration more than 1 year and less than 5 years.
- Patient with Lead size 7F
- BMI 22-32
- Number of implanted leads 1-3
Who cannot join
- Lead implant duration is less than 1 year or more than 5 years.
- Patients with acute and chronic lead infections
- Pericardial or subcutaneous CIED systems (without trans venous CIED lead)
- Pregnant or lactating.
- Patients with expected survival of less than 1 year.
- Subjects who are participating in another clinical study.
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- Subjects who are unable or unwilling to follow the study schedule of visits.
- Contraindication to administration of iodinated contrast (creatinine > 2.0 or contrast allergy)
- Patients with a history of venous thromboembolism, coagulopathy or malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Investigational Study to Assess the Safety and Performance of LeadExx LC System in Lead Extraction
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System and its ability to safely extract leads.
The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).
Read the detailed description
The use of implantable cardiac devices has been exponentially increasing, and lead extraction has become a necessary procedure. But lead extraction has potentially serious complications, including venous or myocardial tear, cardiac tamponade, and even death. Powered sheaths, such as Excimer laser or a radiofrequency system, have been used for extraction of ICD or pacemaker leads. However, the Heart Rhythm Society (HRS) has stated that "possible predictors of major complications were implant duration of the oldest lead, female gender, ICD lead removal, and use of the laser extraction technique, multiple leads, and calcified leads".
To reduce the risk of the lead extraction procedure and therefore reduce the number of abandoned leads, LeadExx had developed its system.
The LC system is an active disposable system provided sterile for single use. The system is comprised of the following two main parts:
- Dilation Unit (DU) - (invasive, sterile) b. Control Unit- (CU) - (non-invasive, sterile fluid path) The physical connection between the units is achieved by 3 Luer locks that connect the CU Solenoids' output to 3 flexible tubes at the proximal end of the DU.
- Dilation Unit (DU): The dilation unit is an invasive sterile unit, comprised of a dilation tip and a connecting shaft. The unit is activated using a hydraulic mechanism. The dilation tip is threaded over the lead, inserted into the vessel together with its connecting shaft and while advancing along the lead, dilates the surrounding tissue and ultimately enables the lead removal from the vein.
- Control Unit (CU):
The Control Unit is a non-invasive fluid path sterile unit, comprised of various off the shelf modules . The unit is being filled with sterile Saline just prior to its operation and by synchronizing the transfer of the Saline into the DU controls its advancement. I
- Conditions
- Implant Site Infection
- Being tested
- LC System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC SystemDevice
Subjects will undergo CIED lead extraction with the LC system
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Subjects who are scheduled for CIED lead extraction with the LC system Receives: Device: LC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Monitoring Adverse events that are related to the extraction procedure, or the extraction system
Measured: 1 month
Secondary outcomes (2)
Performance
Secondary Objectives:
To assess the ease of use by questions
- Duration of procedure,
- Physician satisfaction by questions
Measured: During procedure
Practical removal of intact lead
Performance primary objective:
To verify that the attachment and advancement of the LC system enables a safe and practical removal of the Lead.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startFeb 2017
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LeadExx Cardiac Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Nof, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996929
- Sponsor's protocol ID
- Leadexx CL-001
- Status last verified
- Dec 2016
- First submitted
- 11 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Investigational Study to Assess the Safety and Performance of LeadExx LC System in Lead Extraction
- ClinicalTrials.gov ID
- NCT02996929
- Acronym / sponsor ID
- Leadexx CL-001
- Conditions
- Implant Site Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- LeadExx Cardiac Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2017
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 19 Dec 2016 (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 study's main purpose is to evaluate the safety and performance of the LeadExx LC System and its ability to safely extract leads.
The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).
Detailed description
The use of implantable cardiac devices has been exponentially increasing, and lead extraction has become a necessary procedure. But lead extraction has potentially serious complications, including venous or myocardial tear, cardiac tamponade, and even death. Powered sheaths, such as Excimer laser or a radiofrequency system, have been used for extraction of ICD or pacemaker leads. However, the Heart Rhythm Society (HRS) has stated that "possible predictors of major complications were implant duration of the oldest lead, female gender, ICD lead removal, and use of the laser extraction technique, multiple leads, and calcified leads".
To reduce the risk of the lead extraction procedure and therefore reduce the number of abandoned leads, LeadExx had developed its system.
The LC system is an active disposable system provided sterile for single use. The system is comprised of the following two main parts:
- Dilation Unit (DU) - (invasive, sterile) b. Control Unit- (CU) - (non-invasive, sterile fluid path) The physical connection between the units is achieved by 3 Luer locks that connect the CU Solenoids' output to 3 flexible tubes at the proximal end of the DU.
- Dilation Unit (DU): The dilation unit is an invasive sterile unit, comprised of a dilation tip and a connecting shaft. The unit is activated using a hydraulic mechanism. The dilation tip is threaded over the lead, inserted into the vessel together with its connecting shaft and while advancing along the lead, dilates the surrounding tissue and ultimately enables the lead removal from the vein.
- Control Unit (CU):
The Control Unit is a non-invasive fluid path sterile unit, comprised of various off the shelf modules . The unit is being filled with sterile Saline just prior to its operation and by synchronizing the transfer of the Saline into the DU controls its advancement. I
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: LC SystemSubjects who are scheduled for CIED lead extraction with the LC system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 18-75 years old.
- Scheduled for an CIED lead extraction upon current guidelines
- Willing and able to sign the informed consent.
- Lead implant duration more than 1 year and less than 5 years.
- Patient with Lead size 7F
Key exclusion criteria (9 listed)
- Lead implant duration is less than 1 year or more than 5 years.
- Patients with acute and chronic lead infections
- Pericardial or subcutaneous CIED systems (without trans venous CIED lead)
- Pregnant or lactating.
- Patients with expected survival of less than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC SystemSubjects will undergo CIED lead extraction with the LC system | Device | Study group |
Primary outcome
Adverse events
Time frame: 1 month
Monitoring Adverse events that are related to the extraction procedure, or the extraction system
2 secondary outcomes
Performance
Time frame: During procedure
Practical removal of intact lead
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Eyal Nof, Dr. principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing LC System in people with Implant Site Infection, run by LeadExx Cardiac Ltd..
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyal Nof, Dr. (972-3-530-3810, Eyal.Nof@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 1 month). 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 19 Dec 2016.