Paroxysmal atrial fibrillation
Conditions
Interventions
Cryoballoon ablation group:Fourth generation Cryoballoon ablation
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged between 18 and 80 years old, inclusive (including 18 and 80 years old). (2) Patients with symptomatic paroxysmal atrial fibrillation. (3) Ability to comprehend the purpose of the trial, voluntary participation in the study, and willingness to sign the informed consent form, as well as a commitment to completing the follow-up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible causes. (2) Prior surgical or catheter ablation treatment for atrial fibrillation. (3) History of left atrial appendage occlusion or closure surgery. (4) Myocardial infarction (MI) or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months. (5) Carotid artery stenting or carotid endarterectomy within the past 6 months. (6) Baseline left ventricular ejection fraction (LVEF) 46mm. (8) Presence of implanted devices such as ICD, CRT, and pacemakers. (9) QRS width >120ms or QTc interval >440ms on surface ECG. (10) Imaging evidence of left atrial or left atrial appendage thrombus. (11) Rheumatic heart disease. (12) Uncontrolled hypertension. (13) Hypertrophic cardiomyopathy. (14) Documented thromboembolic events within the past 6 months, including transient ischemic attacks. (15) Presence of intracardiac thrombus, tumors, or other abnormalities hindering vascular puncture or catheter manipulation. (16) Severe pulmonary diseases, pulmonary hypertension, or any pulmonary condition causing gas exchange abnormalities or severe respiratory distress. (17) Previous pulmonary vein stenting or pulmonary vein stenosis. (18) Previous phrenic nerve paralysis. (19) Contraindications to anticoagulation and a history of blood clotting or bleeding abnormalities. (20) Acute systemic infection. (21) Serum creatinine greater than twice the normal upper limit, severe renal dysfunction (eGFR <30), or any history of renal dialysis. (22) Pregnant or lactating females or females unable to use contraception during the trial. (23) Expected life expectancy less than 12 months (e.g., advanced malignancy). (24) Other anomalies or diseases deemed by the investigator to warrant exclusion from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term success rate (proportion of maintained sinus rhythm);Postoperative Major Adverse Events (MAE) Related to Devices or Surgery Incidence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate: Refers to maintaining pulmonary vein electrical isolation after all pulmonary vein ablation is completed;Incidence Rate of AT/AFL/AF Events Within the 3-Month Blanking Period;Rehospitalization Rate Due to Cardiovascular Events During Follow-up;Improvement in Quality of Life; | — |
Countries
China
Contacts
Public ContactRui Zeng
West China Hospital, Sichuan University
Outcome results
None listed