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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT06078735
Eligibility Criteria:
Inclusion Criteria:
* Must be at least 18 years of age
* Be able to provide consent
* Presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a LockeT device or MC to close the wound.
Exclusion Criteria:
* Under the age of 18
* Unable to or unwilling to provide consent
* Cannot comply with study requirements
* Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle
* Subjects whose physician does not use LockeT or MC to close the venous puncture.
* Patient is currently pregnant, as evidenced by positive urine Beta-HCG. (Urine Beta Human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
* If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06078735
Study Brief:
Protocol Section:
NCT06078735