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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT03520868
Eligibility Criteria:
Inclusion Criteria:
* All adults, male and female, aged 18 and above.
* Patients with paroxysmal, persistent or chronic AF
* All patients must be on therapeutic doses of Coumadin or one of the NOACs for at least 1 month prior to the procedure.
Exclusion Criteria:
* Patients with known primary or secondary coagulopathy (such as Hemophilia, vWF deficiency, active malignancy, ATIII deficiency, Factor V Leiden deficiency, Hx of recurrent DVT/PE)
* Patients with hypoalbuminemia, cirrhosis
* chronic LMWH therapy,
* ESRD on HD, and severely impaired kidney function with CKD stage IV
* BMI \>35
* prosthetic heart valves and
* advanced liver disease
* previous procedural complications such as tamponade
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03520868
Study Brief:
Protocol Section:
NCT03520868