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| Name | Class |
|---|---|
| KCRI | OTHER |
| Scopus Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety related to the lead extraction procedure, or the extraction tool | To collect and evaluate device- and procedure-related adverse events. | 0 to 30 days post-lead extraction |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During procedure |
| To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uri Stein, PhD | Contact | +972525801916 | uri@xtrac-medical.com | |
| Liron Hason, Bsc | Contact | +972543838100 | Liron.h@scopus-cro.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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.
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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 |
| 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 | Acute setting (during the surgical procedure) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |