The goal of this prospective, observational study is to evaluate the safety and efficacy of a cardiac surgical cryoablation system for the treatment of atrial fibrillation. This study will be conducted at Fuwai Hospital in China. A total of 10 subjects with heart valve diseases (e.g., mitral, tricuspid, and aortic valve diseases) requiring surgical treatment and with atrial fibrillation will be enrolled in the study, and all of them will undergo surgical ablation using surgical cryoablation devices (cryoablation clamps and pens) with follow-up visits at 3 and 6 months after the procedure. In this study, the incidence of cardiac and cerebrovascular-related adverse events in the perioperative period and at 6 months after procedure is defined as the primary safety endpoint (all-cause mortality, stroke, systematic embolism, cardiac reoperations, heart failure requiring hospitalization, ablation-related coronary artery stenosis/occlusion, pulmonary vein stenosis, and rate of permanent pacemaker implantation.). The primary efficacy endpoint is the probability of freedom from atrial tachyarrhythmias at 6 months after the procedure. Device ease of use, technical success, ablation procedure time, and assessment of the incidence of device defects are defined as secondary endpoints.
patients with valvular disease (e.g., mitral, tricuspid, and aortic valve disease) requiring surgical intervention;
patients with atrial fibrillation who consent to cryoablation;
18-75 years of age (as of the date of signing the informed consent form);
signing the patient's informed consent.
intracardiac thrombosis;
patients with absolute contraindications to anticoagulation;
combination of other cardiac diseases requiring surgical treatment;
patients with a diagnosis of coronary artery disease (coronary artery enhancement CT or coronary angiography suggesting that any one of the three coronary vessels and their major branches has a stenosis greater than or equal to 50%);