Paroxysmal atrial fibrillation
Conditions
Interventions
Single unit:Cryoablation
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old, regardless of gender; 2. The patient was clinically diagnosed as paroxysmal atrial fibrillation. 3. The patient is willing to evaluate the clinical protocol requirements; 4. Prior to treatment, subjects (or their guardians) agreed to participate in the study and signed an EC-approved informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone left atrial appendage closure; 2. Patients who had undergone left atrial ablation or left atrial surgery in the past; 3. Patients who have undergone valve repair; 4. Severe organic heart disease, including rheumatic heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc; 5. Have a history of anticoagulant contraindications or bleeding disease within 6 months; 6. Patients with thrombus in left atrial/left auricle before operation; 7. Echocardiography showed that the anterior and posterior diameter of the left atrium was >=50mm; 8. LVEF(%) is less than 40%; 9. Patients fitted with one or more pulmonary vein stents; 10. The patient had undergone atrial septal repair or other surgical procedures in or near the atrial septum; 11. Other conditions assessed by the investigators as unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate 12 months after operation;To study the incidence of device-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;Therapeutic effectiveness;Number of cryoablation/pulmonary veins;Cryoablation time;Instrument performance evaluation;Incidence of complications; | — |
Countries
China
Contacts
Public ContactNie Zhenning
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed