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 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT01103661
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years; \< 80 years
* Left atrium less than or equal to 6.5 cm (TTE)
* History of AF for less than or equal to 10 years
* Provided written informed consent
* Symptomatic longstanding persistent Atrial Fibrillation (AF).
Exclusion Criteria:
* Patients requiring concomitant surgery
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* Measured left ventricular wall thickness \> 1.5 cm
* History of coagulopathy
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA), excluding fully resolved TIA
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF
* Patients who are contraindicated for anticoagulants
* Patients who are being treated for arrhythmias other than AF
* Patients who have had any previous AF or left atrial catheter ablation
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
* Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01103661
Study Brief:
Protocol Section:
NCT01103661