Paroxysmal atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old and <= 75 years old; 2. Paroxysmal atrial fibrillation diagnosed by electrocardiogram or dynamic electrocardiogram; 3. Catheter ablation is planned; 4. Be able to understand the purpose of the research, show sufficient compliance with the research protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Previously received radiofrequency ablation or other left atrial surgery; 2. Patients with cardiac function class (NYHA) III-IV; 3. Left ventricular ejection fraction (LVEF) 50 mm; 6. Patients with implanted cardiac pacemakers and defibrillators; 7. Patients with acute or severe systemic infection before operation; 8. Patients with stroke and other cerebrovascular diseases within 3 months before enrollment; 9. Patients with obvious bleeding tendency who cannot accept antiplatelet aggregation and/or anticoagulant therapy; 10. Patients with known dementia or mental illness; 11. Severe structural heart disease, including moderate-severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic heart disease, etc.; 12. Pregnant or breastfeeding women, or those who have a family plan within the next year; 13. Combined with other serious diseases before operation, or life expectancy less than 1 year; 14. Are participating in any other drug or medical device clinical trials, or may participate in any other drug or medical device clinical trials after being enrolled in this clinical trial; 15. The investigator judges that there are other conditions that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate after operation;Incidence of atrial tachyarrhythmias 1 month, 3 months, 6 months, and 12 months postoperatively;EQ-5D scale scores for 6 months and 12 months postoperatively; | — |
Countries
China
Contacts
Hangzhou Ruidi Biotechnology Ltd.