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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT07039032
Eligibility Criteria:
Inclusion Criteria:
1. Patient age between 18 and 80 years old, male or non-pregnant female.
2. Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation surgery.
3. Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.
Exclusion Criteria:
1. Post-ablation for atrial fibrillation
2. Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
3. Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
4. Left atrial thrombus
5. History of atrial septal defect repair or atrial myxoma
6. History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
7. History of cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision)
8. Patients with acute or severe systemic infection
9. Patients with severe liver or kidney disease
10. Patients with significant bleeding tendencies or haematological disorders
11. Patients with malignant tumours or end-stage diseases
12. Patients deemed ineligible for this trial by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07039032
Study Brief:
Protocol Section:
NCT07039032