Clinical trial NCT06115980: Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Official title: First in Man, Open-label, Multi Center Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bradycardia
Lead sponsor: Xtrac O.S.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
name: Scopus Research
First posted: 2023-11-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Men or Female patients, 18-85 years old.
2. 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.
3. Scheduled for a CIED lead extraction upon current guidelines.
4. Lead implant duration more than 1 year and less than 5 years.
5. Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
6. Patients are classified as ASA II/III.
7. Leads with external diameter of 7Fr-9Fr.

Exclusion Criteria:

1. Patient age \> 85 years old.
2. Hemodynamic instability.
3. Class IV NYHA heart failure.
4. Contrast allergy.
5. Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
6. Patients who are placed on a heparin bridge, and are felt to be high risk for even brief discontinuation of anticoagulation
7. Pregnant or lactating.
8. 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.

Primary outcomes:
measure: To evaluate safety related to the lead extraction procedure, or the extraction tool
timeFrame: 0 to 30 days post-lead extraction
Secondary outcomes:
measure: To assess the ease of use, duration of the procedure and the physician satisfaction by questions by a Likert scale
timeFrame: During procedure
measure: To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years
timeFrame: Acute setting (during the surgical procedure)
measure: To evaluate the rate of clinical procedural success
timeFrame: Acute setting (during the surgical procedure)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References: