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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT02968056
Eligibility Criteria:
Inclusion Criteria
1. Isolated atrial fibrillation, without structural heart disease.
2. Persistent atrial fibrillation (Af last time \> 7 days, including persistent long standing atrial fibrillation)
3. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these.
4. Patient admitted with intent to treat by either hybrid or surgical ablation
5. Consent
Exclusion Criteria
1. Previous surgical ablation of atrial fibrillation
2. Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
3. With other forms of severe arrhythmia
4. Ejection fraction of left ventricle less than 30%
5. Anteroposterior diameter of left atrial over 60mm
6. Tumor, active infection, pregnancy.
7. Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc.
8. Hyperthyroidism
9. Thrombosis within left atrial appendage
10. General conditions too weak to tolerate the surgeries
11. Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 1-year follow-up
12. Other conditions not appropriate for this study based on the investigators' judgments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02968056
Study Brief:
Protocol Section:
NCT02968056