paroxysmal atrial fibrillation
Conditions
Interventions
Experimental group:Cardiac cryoablation system
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=age=75 years old; 2. Paroxysmal atrial fibrillation with symptoms; 3. Be able to understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Echocardiography shows that the left atrium diameter is greater than or equal to 50mm, and LVEF is less than or equal to 40%; 2. CT or TEE examination suggests that there is a thrombus in the left atrium/left atrial appendage; 3. Have received atrial fibrillation ablation or left atrial surgery; 4. Have received left atrial appendage closure or plan to undergo a one-stop operation for atrial fibrillation ablation and left atrial appendage closure; 5. Have performed valve repair surgery; 6. New York heart function class (NYHA) class III or IV; 7. The presence of typical atrial flutter or persistent supraventricular tachycardia confirmed by electrocardiogram or Holter before surgery; 8. Secondary atrial fibrillation; 9. Cardiovascular events (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) within 3 months before enrollment; 10. Have cerebrovascular disease (stroke) within 6 months before enrollment; 11. Contraindications to anticoagulation therapy and serious blood system diseases; 12. Severe structural heart disease; 13. Life expectancy <12 months; 14. Female patients of childbearing age with positive pregnancy test; 15. Participating in other drug or device clinical studies that have not been completed; 16. There are circumstances that other investigators think it is not appropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate of surgery;Blank period recurrence rate;Early recurrence rate;Operation time;surgical ablation time;Number of cryoablations/time;In place ratio;Mapping success rate;Device use evaluation; | — |
Countries
China
Contacts
Public ContactMinglong Chen Director
Outcome results
None listed