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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00950092
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years; \< 80 years
* Left atrium =\< 6.0 cm
* Documented persistent or longstanding persistent AF
* History of AF =\< 10 years
* Scheduled for a concomitant cardiac procedure
* Coronary bypass surgery (CABG)
* Mitral valve repair/replacement
* Aortic valve replacement
* ASD repair
* Tricuspid valve repair/replacement
* Myxoma
* Any combination of the above procedures
* Provided written informed consent
Exclusion Criteria:
* Left atrial size \> 6.0 cm (pre-op TTE - parasternal 4 chamber view)
* History of AF \> 10 years
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* History of coagulopathy
* Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA)
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
* Patients who are being treated for ventricular arrhythmias
* Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
* 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:
NCT00950092
Study Brief:
Protocol Section:
NCT00950092