Actively Recruiting
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Led by Xtrac O.S. · Updated on 2024-08-13
10
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
X
Xtrac O.S.
Lead Sponsor
K
KCRI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or female patients aged 18 to 85 years
- Patients who understand the study procedures and agree to sign informed consent
- Scheduled for cardiac implantable electronic device lead extraction following current guidelines
- Lead implant duration between more than 1 year and less than 5 years
- Negative for SARS-CoV-2 and no Covid-19 signs or symptoms before enrollment
- Classified as ASA physical status II or III
- Leads with external diameter between 7Fr and 9Fr
You will not qualify if you...
- Patient older than 85 years
- Hemodynamic instability
- Class IV New York Heart Association heart failure
- Allergy to contrast agents
- Considered high risk due to acute illness or systemic comorbidities
- On a heparin bridge and high risk for anticoagulation interruption
- Pregnant or breastfeeding
- Participation in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
Research Team
U
Uri Stein, PhD
CONTACT
L
Liron Hason, Bsc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here