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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05655468
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-80 years;
2. Diagnosis of non-paroxysmal AF
3. Undergoing AF ablation for the first time
Exclusion Criteria:
1. Unwilling to take or intolerant to dronedarone;
2. Hypersensitivity to the drug ingredient
3. Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40%
4. Bradycardia \<50 bpm
5. QTc Bazett interval ≥500ms or PR interval \>280ms
6. II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker
7. Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months
8. Patients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness \>15mm, congenital heart disease)
9. Accepted cardiac surgery within the last 3 months
10. Left atrial diameter (LAD) \>55 mm
11. Patients with left atrial or left auricular thrombosis
12. Patients with Hyperthyroidism
13. Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR\<30ml/min/1.73m2)
14. Abnormal blood coagulation
15. Concomitant use of dabigatran
16. Concomitant use of drugs that prolong QTc or may induce torsades de pointes
17. Concomitant use of strong CYP3A inhibitors
18. Concomitant use of another Class IA, IC, or III AADs
19. Patients suffering from serious infection, mental illness or malignant tumors
20. Pregnancy or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05655468
Study Brief:
Protocol Section:
NCT05655468