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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01520532
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years old
* Subject has been diagnosed with atrial fibrillation (AF)
* Subject is indicated for a pulmonary vein ablation using PVAC
* Subject (or subject's legally authorized representative) is able and and willing to give informed consent.
Exclusion Criteria:
* Subject has permanent AF
* Subject has a left atrial thrombus detected on TEE
* Subject has had a prior left atrial ablation
* Subject has a intracardiac thrombus
* Subject is contraindicated for Warfarin (Coumadin)
* Subject has a cardiac valve prosthesis
* Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
* Subject has presence of any pulmonary vein stents
* Subject has presence of any pre-existing pulmonary vein stenosis
* Subject has had a cerebral ischemic event (strokes or transient ischemic attacks \[TIA\]) which occurred during the 6 month interval preceding the Consent Date
* Subject is a woman known to be pregnant
* Subject is unwilling or unable to comply fully with study procedures and follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01520532
Study Brief:
Protocol Section:
NCT01520532