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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT06699368
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged between 18 and 80 years old.
2. Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.
3. Non-valvular atrial fibrillation.
4. Able to understand the purpose of the study, voluntarily participate in this research, and the patient or their legal representative signs the informed consent form, willing to complete follow-ups as required by the protocol.
Exclusion Criteria:
1. Atrial fibrillation secondary to thyroid disease or other reversible factors;
2. Imaging studies indicating intracardiac thrombus;
3. Moderate to severe mitral stenosis or regurgitation;
4. Left ventricular ejection fraction \<40%, or New York Heart Association (NYHA) functional class III or IV;
5. Unstable angina;
6. Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;
7. Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;
8. Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;
9. Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;
10. Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;
11. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;
12. Conditions affecting vascular access;
13. Patients who are concurrently participating in other drug or device clinical trials;
14. Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06699368
Study Brief:
Protocol Section:
NCT06699368