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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07403760
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 80 years.
2. Documented paroxysmal or persistent atrial fibrillation by ECG or Holter within 6 months prior to enrollment.
3. Symptomatic AF (including palpitations, chest tightness, fatigue, dizziness, blackouts, dyspnea).
4. Voluntary participation and signed informed consent.
Exclusion Criteria:
1. NYHA Class IV heart failure.
2. Acute myocardial infarction, cardiac surgery, or PCI within the past 1 year.
3. Long-standing persistent AF (duration \> 1 year).
4. Left atrial anteroposterior diameter \> 6 cm.
5. History of prior AF ablation.
6. AF secondary to reversible causes (e.g., post-surgery, infection, hyperthyroidism).
7. Severe mitral stenosis.
8. Moderate to severe hepatic failure (Child-Pugh B-C).
9. Renal failure stage 4-5 (eGFR \<30 ml/min/1.73m2) or continuous dialysis.
10. Inability to cooperate due to dementia or severe mental disorder.
11. Presence of left atrial thrombus.
12. Prior Left Atrial Appendage Occlusion (LAAO).
13. Contraindication to anticoagulation.
14. Life expectancy \< 1 year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
80 Years
Study:
NCT07403760
Study Brief:
Protocol Section:
NCT07403760