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 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT01585961
Eligibility Criteria:
Inclusion Criteria:
* Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
* Age 18 years or older
* Patients must be able and willing to provide written informed consent to participate in the study
Exclusion Criteria:
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for atrial fibrillation
* Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease in which corrective surgery is anticipated within 6 months
* Enrollment in investigational drug, biologic or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01585961
Study Brief:
Protocol Section:
NCT01585961