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 @ 2:34 PM
Ignite Modification Date:
2025-12-24 @ 2:34 PM
NCT ID:
NCT07095959
Eligibility Criteria:
Inclusion Criteria:
1. Age over 18 years;
2. With symptomatic\* paroxysmal AF;
3. Undergoing first AF ablation;
4. At least one AF lasting over 30s documented by 12-lead ECG, Holter, or other rhythm monitoring device in the past 12 months;
5. Able to understand the purpose of the study, willing to receive randomization of the ablation strategy, and able to be followed up as required, voluntarily participate in the study and signed a written informed consent.
* Symptoms include but not restricted to palpitations, dizziness, fatigue, or shortness of breath and chest discomfort
Exclusion Criteria:
1. Diagnosed with persistent atrial fibrillation or duration of atrial fibrillation \>7 days;
2. Thrombosis in the heart cavity;
3. Contraindications to oral anticoagulants including the presence of a history of heparin-induced thrombocytopenia;
4. Transient/reversible atrial fibrillation due to electrolyte disorders, thyroid disease or other non-cardiac-related causes;
5. Acute coronary syndrome in the past 3 months or coronary intervention or coronary artery bypass treatment;
6. Stroke or transient ischemic attacks (TIA) in the past 3 months;
7. History of cardiac surgery or other surgical history involving left atrium, such as previous left atrial catheter ablation, atrial septal defect repair, etc.;
8. History of previous severe valvular disease (severe mitral stenosis or regurgitation), congenital heart disease, hypertrophic cardiomyopathy or dilated cardiomyopathy;
9. TEE examination in the past 12 months showed that the left atrium diameter of the parasternal long axis section was ≥55mm;
10. Other factors that are not suitable for surgery (such as history of organ transplant surgery or ongoing evaluation of organ transplant surgery, life expectancy less than 1 year, uncontrolled cancer, pregnancy, breastfeeding, or planning to get pregnant, etc.);
11. Other patients who were not suitable for enrollment in this study after the investigator's evaluation;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07095959
Study Brief:
Protocol Section:
NCT07095959