BradycardiaXTRNCT06115980
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
A study testing lead extraction (Xtrac O.S. system) in people with Bradycardia, run by Xtrac O.S. at 1 site in Israel.
Trial summary
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bradycardia
- What is being tested?
- lead extraction (Xtrac O.S. system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Aug 2023to 20 Jul 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or Female patients, 18-85 years old.
- Patients must understand the procedures and methods of this study and be willing to sign the informed consent form and to complete the trial in strict accordance with clinical trial protocol.
- Scheduled for a CIED lead extraction upon current guidelines.
- Lead implant duration more than 1 year and less than 5 years.
- Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
- Patients are classified as ASA II/III.
- Leads with external diameter of 7Fr-9Fr.
Who cannot join
- Patient age > 85 years old.
- Hemodynamic instability.
- Class IV NYHA heart failure.
- Contrast allergy.
- Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
- Patients who are placed on a heparin bridge, and are felt to be high risk for even brief discontinuation of anticoagulation
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- Pregnant or lactating.
- Participating in another clinical study.
- Eligibility will be determined by the PI and investigators based on the exclusion/inclusion criteria, current medical status and evaluation of the procedure risks mitigation.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Yair Elitzur, M.D, 02-6773401, elitzur1970@gmail.com
Yair Elitzur, M.D
About this study
Official title: First in Man, Open-label, Multi Center Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.
A total of 15 patients, who are scheduled for CIED lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up.
- Conditions
- Bradycardia
- Being tested
- lead extraction (Xtrac O.S. system)
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lead extraction (Xtrac O.S. system)Device
This is an open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.
The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).
Each enrolled patient will undergo a pre procedural evaluation to enable planning of the extraction procedure. The evaluation includes an assessment of the CIED components to be removed, dwell time, anatomic course on radiography and patient characteristics that may require management prior to extraction.
A multidisciplinary team evaluation involving cardiac surgery, electrophysiologist, and cardiac anesthesiology should allow for a rapid and successful response to major complications
| Study group | Role | What they receive |
|---|---|---|
| 1 - An open label study | Experimental | This is an open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.
A total of 15 patients, who are scheduled for lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up. Receives: Device: lead extraction (Xtrac O.S. system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety related to the lead extraction procedure, or the extraction tool
To collect and evaluate device- and procedure-related adverse events.
Measured: 0 to 30 days post-lead extraction
Secondary outcomes (3)
To assess the ease of use, duration of the procedure and the physician satisfaction by questions by a Likert scale
Using Likert scale (1 - Poor; 2 - Fair; 3 - Good; 4 - Excellent)
Measured: During procedure
To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years
Complete procedural success is the removal of the targeted lead and all lead material from the vascular space, with the absence of permanently disabling complications or procedure-related death
Measured: Acute setting (during the surgical procedure)
To evaluate the rate of clinical procedural success
Clinical procedural success is the removal of all targeted leads and all lead material from the vascular space, or retention of a small portion of the lead (fragment that is 4 cm or smaller) that does not negatively impact the outcome goals of the procedure
Measured: Acute setting (during the surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start27 Aug 2023
- Primary completion15 May 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach. A total of 10 patients, who are scheduled for lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA). Each enrolled patient will undergo a pre procedural evaluation to enable planning of the extraction procedure. The evaluation includes an assessment of the CIED components to be removed, dwell time, anatomic course on radiography and patient characteristics that may require management prior to extraction.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xtrac O.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI, Scopus Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115980
- Sponsor's protocol ID
- XTR-01-0322
- Acronym
- XTR
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Man, Open-label, Multi Center Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
- ClinicalTrials.gov ID
- NCT06115980
- Acronym / sponsor ID
- XTR / XTR-01-0322
- Conditions
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xtrac O.S.Industry (pharma, biotech, devices)
- Collaborators
- KCRI, Scopus Research
- Study start
- 27 Aug 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 3 Nov 2023 (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.
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.
A total of 15 patients, who are scheduled for CIED lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach. A total of 10 patients, who are scheduled for lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA). Each enrolled patient will undergo a pre procedural evaluation to enable planning of the extraction procedure. The evaluation includes an assessment of the CIED components to be removed, dwell time, anatomic course on radiography and patient characteristics that may require management prior to extraction.
| Arm | Type | Receives |
|---|---|---|
| 1 - An open label study | Experimental | Device: lead extraction (Xtrac O.S. system)This is an open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach. A total of 15 patients, who are scheduled for lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or Female patients, 18-85 years old.
- Patients must understand the procedures and methods of this study and be willing to sign the informed consent form and to complete the trial in strict accordance with clinical trial protocol.
- Scheduled for a CIED lead extraction upon current guidelines.
- Lead implant duration more than 1 year and less than 5 years.
- Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
Key exclusion criteria (9 listed)
- Patient age > 85 years old.
- Hemodynamic instability.
- Class IV NYHA heart failure.
- Contrast allergy.
- Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
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 |
|---|---|---|
| lead extraction (Xtrac O.S. system)This is an open label, non-randomized, feasibility, prospective, interventional clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA). Each enrolled patient will undergo a pre procedural evaluation to enable planning of the extraction procedure. The evaluation includes an assessment of the CIED components to be removed, dwell time, anatomic course on radiography and patient characteristics that may require management prior to extraction. A multidisciplinary team evaluation involving cardiac surgery, electrophysiologist, and cardiac anesthesiology should allow for a rapid and successful response to major complications | Device | 1 - An open label study |
Primary outcome
To evaluate safety related to the lead extraction procedure, or the extraction tool
Time frame: 0 to 30 days post-lead extraction
To collect and evaluate device- and procedure-related adverse events.
3 secondary outcomes
To assess the ease of use, duration of the procedure and the physician satisfaction by questions by a Likert scale
Time frame: During procedure
To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years
Time frame: Acute setting (during the surgical procedure)
To evaluate the rate of clinical procedural success
Time frame: Acute setting (during the surgical procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lead extraction (Xtrac O.S. system) in people with Bradycardia, run by Xtrac O.S. at 1 site in Israel.
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 13 Aug 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Stein, PhD (+972525801916, uri@xtrac-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety related to the lead extraction procedure, or the extraction tool (time frame: 0 to 30 days post-lead extraction). 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 13 Aug 2024.