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
Single group
IceMagic™ CryoAblation Catheter
DeviceIceMagic™ CryoAblation Catheter is available in two diameters: 23 mm and 28 mm. Each diameter has two types of balloon outer surfaces: with or without multi-channel tissue temperature measurement function. The catheter length is 140 cm, and the tube diameter is 10.5 F. Doctors can choose according to the size of the target pulmonary vein.
Three-month follow-up success rate after surgery
Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period post-surgery (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants.
Immediate ablation success rate
This refers to the proportion of subjects who achieved electrical isolation after surgery among the total number of patients enrolled in the study. The verification method involves waiting for 20 minutes after successful pulmonary vein electrical isolation and then reconfirming pulmonary vein conduction block.
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Shanghai MicroPort EP MedTech Co., Ltd.
Lead sponsor
West China Hospital
Sponsor institution
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