atrial fibrillation
Conditions
Interventions
Experimental group:iASD cryoballoon ablation
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with atrial fibrillation through electrocardiogram and Holter monitoring prior to enrollment; 2. Patients undergoing catheter-based cryoballoon ablation for atrial fibrillation; 3. Age 18 or older; 4. Consent to participate in this study, with the ability to understand and sign the informed consent form, and have good clinical compliance to complete the post-operative clinical follow-up required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Prior left atrial ablation or cardiac surgery (including left atrial appendage closure); 2. History of atrial septal defect closure/occlusion; 3. History of prior transseptal puncture; 4. Known history of atrial septal defect (ASD); 5. Known history of patent foramen ovale (PFO); 6. Pre-existing pulmonary vein stent; 7. Pre-existing pulmonary vein stenosis; 8. History of pre-existing unilateral phrenic nerve palsy; 9. Presence of any cardiac valve prosthesis; 10. Presence of moderate-to-severe (grade 3-4) mitral regurgitation or mitral stenosis; 11. Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI)/percutaneous transluminal coronary angioplasty (PTCA), or coronary stenting within three months prior to signing consent; 12. Unstable angina pectoris; 13. Rheumatic heart disease; 14. Any condition contraindicating long-term anticoagulation therapy; 15. Active systemic infection; 16. Cryoglobulinemia; 17. Women known to be pregnant or breastfeeding; 18. Life expectancy less than one year; 19. Current or anticipated participation in any other investigational drug, device, or biologic trial during the study period; 20. Presence of intracardiac thrombus; 21. Known drug or alcohol addiction; 22. Patients unwilling or unable to fully comply with the study protocol and complete follow-up; 23. Patients with severe renal insufficiency, eGFR < 30 umol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of iASD after 6 months of cryoballoon ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate after 6/12 months of cryoballoon ablation;Surgical complication record; | — |
Countries
China
Contacts
Public ContactWu Xinlei
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed