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A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation
Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-08-31
Completion Date
2027-12-31
Last Updated
2025-06-27
Healthy Volunteers
No
Conditions
Interventions
IceMagic™ CryoAblation Catheter
IceMagic™ 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.
Locations (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China