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 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07321002
Eligibility Criteria:
Inclusion Criteria:
1\. Aged 18-75 years (inclusive). 2. Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment:
1. A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period.
2. Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF.
3\. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD).
4\. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written informed consent.
Exclusion Criteria:
1. Paroxysmal atrial fibrillation (AF)；
2. AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies；
3. Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias；
4. Patients with sustained ventricular tachycardia or ventricular fibrillation；
5. Left atrial anteroposterior diameter \> 55 mm；
6. Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation；
7. History of left atrial ablation or cardiac surgery (including left atrial appendage closure)；
8. Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)；
9. Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities；
10. Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities；
11. Any of the following cardiac surgeries, implants, or conditions:
* Prosthetic heart valve
* NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 40%
* Atrial septal defect or ventricular septal defect closure
* Atrial myxoma, left atrial appendage device implantation or occlusion
12. History of any of the following within 3 months prior to the procedure:
* Myocardial infarction
* Unstable angina
* Percutaneous coronary intervention
* Cardiac surgery (including coronary artery bypass grafting)
* Hospitalization for heart failure
* Pericarditis
13. History of any of the following within 3 months prior to the procedure:
* Cerebral infarction or transient ischemic attack (TIA)
* Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography \[TEE\])
14. History of malignant tumor or expected life expectancy \< 12 months；
15. Mental disorders or history of mental illness with inability to cooperate independently；
16. Lactating, pregnant, or women planning or potentially becoming pregnant；
17. Acute or severe systemic infection, or significant abnormalities in liver/renal function；
18. Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07321002
Study Brief:
Protocol Section:
NCT07321002