Status:
RECRUITING
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Lead Sponsor:
Xtrac O.S.
Collaborating Sponsors:
KCRI
Scopus Research
Conditions:
Bradycardia
Eligibility:
All Genders
18-85 years
Phase:
NA
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 le...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06115980
Start Date
August 27 2023
End Date
July 20 2025
Last Update
August 13 2024
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel