Evaluating the Xtrac O.S. System for removing heart leads

First in Man, Open-label, Multi Center Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

This study is testing a new system to safely remove heart leads from patients who have had them in for over a year to see how well it works.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Xtrac O.S. (industry)
• Locations: 1 site (Jerusalem)
• Trial ID: NCT06115980 on ClinicalTrials.gov

What this trial studies

This clinical trial is an open-label, interventional feasibility study aimed at assessing the safety and preliminary performance of the Xtrac O.S. system for the transvenous extraction of pacing or defibrillator leads. A total of 15 patients scheduled for cardiac implantable electronic device (CIED) lead extraction will be recruited, with the goal of having at least 10 patients complete the study procedures and follow-up. The trial will focus on patients with leads implanted for more than one year but less than five years, ensuring they meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18-85 who are scheduled for CIED lead extraction and meet the study's health criteria.

Not a fit: Patients over 85 years old, those with hemodynamic instability, or severe heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective method for lead extraction in patients with bradycardia.

How similar studies have performed: While this approach is novel, similar studies on lead extraction techniques have shown promising results in improving patient outcomes.

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.

Where this trial is running

Jerusalem

• Hadassah Medical Center — Jerusalem, Israel (RECRUITING)

Study contacts

• Study coordinator: Uri Stein, PhD

Conditions: Bradycardia