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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT01246466
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
3. Patient is willing and able to provide written informed consent.
4. Patient has a life expectancy of at least 2 years.
5. Patient is willing and able to attend the scheduled follow-up visits.
Exclusion Criteria:
1. Prior Cardiothoracic Surgery.
2. Patient has NYHA Class IV heart failure.
3. Evidence of underlying structural heart disease requiring surgical treatment.
4. Ejection fraction \< 30%
5. Measured left atrial diameter \> 6.0 cm
6. Renal Failure
7. Stroke within previous 6 months.
8. Known carotid artery stenosis greater than 80%.
9. Evidence of significant active infection or endocarditis.
10. Pregnant woman or women desiring to become pregnant in the next 24 months.
11. Presence of thrombus in the left atrium determined by echocardiography.
12. History of blood dyscrasia.
13. Contraindication to anticoagulation, based on Investigator's opinion.
14. Mural thrombus or tumor.
15. Moderate to Severe COPD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01246466
Study Brief:
Protocol Section:
NCT01246466