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Tests treatment safety and results for Bradycardia
Official title Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
ClinicalTrials.gov ID: NCT06115980
What this study is testing
- What it's testing
- This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.