Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT06627959
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients age \>18
* Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites
* Willing and able to give informed consent
Exclusion Criteria:
* Active systemic or cutaneous infection, or inflammation in vicinity of the groin
* Platelet count \< 100,000 cells/mm3
* BMI \> 45 kg/m2 or \< 20 kg/m2
* Attempted femoral arterial access or inadvertent arterial puncture
* Procedural complications that interfered with routine recovery, ambulation, or discharge times
* Incorrect sheath placement
* Intraprocedural bleeding or thrombotic complications
* Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
* History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06627959
Study Brief:
Protocol Section:
NCT06627959