Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

Last updated: August 12, 2024
Sponsor: Xtrac O.S.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Cardiac Disease

Heart Defect

Treatment

lead extraction (Xtrac O.S. system)

Clinical Study ID

NCT06115980
XTR-01-0322
  • Ages 18-85
  • All Genders

Study 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

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 tosign the informed consent form and to complete the trial in strict accordance withclinical 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, priorto enrollment.

  6. Patients are classified as ASA II/III.

  7. Leads with external diameter of 7Fr-9Fr.

Exclusion

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 systemiccomorbidities.

  6. Patients who are placed on a heparin bridge, and are felt to be high risk for evenbrief 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.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: lead extraction (Xtrac O.S. system)
Phase:
Study Start date:
August 27, 2023
Estimated Completion Date:
July 20, 2025

Connect with a study center

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

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