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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT04199702
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 - Age \< 75 yr
* Documentation of atrial fibrillation (AF) or atypical atrial flutter
* All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements
Exclusion Criteria:
* Heart failure with reduced ejection fraction less than 40%
* Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
* INR \> 4.0 at the time of the procedure
* Mental impairment precluding verbal consent or completing follow up
* Patients with any other significant uncontrolled or unstable medical condition
* Women who are known to be pregnant or have had a positive β-HCG test within 7 days prior to procedure
* Presence of left atrial thrombus
* Patients with prior prostate hypertrophy or bladder surgery
* BMI \> 40 or BMI \<20
* Patients with h/o symptomatic heart failure
* Patients with severe aortic stenosis (AS) or severe mitral regurgitation (MR)
* Patients who require femoral arterial line for blood pressure monitoring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
74 Years
Study:
NCT04199702
Study Brief:
Protocol Section:
NCT04199702