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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01767558
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic AF (\>/=2 recurrent AF episodes that self terminate or AF \</=48 hours that are cardioverted)
* Documentation of \>/=1 paroxysmal AF events within past year
* AF symptoms (e.g. palpitations, fatigue, exertional dyspnea, effort intolerance)
* Prescribed to vitamin K antagonist (e.g. warfarin/coumadin)
* Age 18-70 years old
* Clinically indicated for a pulmonary vein ablation
* Willing and able to give informed consent
* Willing, able and committed to participate in all study required activities for the duration of the study
Exclusion Criteria:
* Diagnosis of persistent or permanent AF
* Prior left atrial ablation
* Presence of intracardiac thrombus
* Contraindicated for vitamin K antagonist
* Prescribed to direct thrombin or factor inhibitors (e.g. dabigatran, rivaroxaban)
* Prescribed to any investigational drug that may confound the study results
* Cardiac valve prosthesis
* Significant congenital heart defect (corrected or not)
* Pulmonary vein stents
* Pre-existing pulmonary vein stenosis
* Cerebral ischemic event (e.g. stroke, TIA) that occurred within 6 months of study consent date
* If female - pregnancy
* Participation in any other cardiovascular clinical study
* Contraindicated for MRI
* Active sepsis
* Blood clotting abnormalities (genetic)
* Presence of left atrial myxoma
* Venous filtering device (e.g. Greenfield filter)
* Invasive cardiac procedure in past 90 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01767558
Study Brief:
Protocol Section:
NCT01767558