To validate the safety and efficacy of balloon cryoablation technology and the accompanying disposable intracardiac mapping electrode catheter and adjustable guide sheath for the treatment of paroxysmal atrial fibrillation.
Patient age between 18 and 80 years old, male or non-pregnant female.
Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery.
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.
Patients who have undergone atrial fibrillation ablation surgery
Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
Left atrial thrombus
Shanghai MicroPort EP MedTech Co., Ltd.
Lead sponsor
West China Hospital
Sponsor institution