Persistent atrial fibrillation
Conditions
Interventions
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years old; 2. Patients with symptomatic persistent atrial fibrillation; 3. Those who are ineffective or intolerable after at least one class I or class III AAD treatment; 4. Willing to participate in the trial and accept the follow-up required by the protocol and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with previous ablation of atrial fibrillation; 2. Previous surgical for atrial fibrillation; 3. Clinically diagnosed long-standing persistent atrial fibrillation; 4. Hemorrhagic stroke within 6 months; 5. Transient ischemic attack or ischemic stroke within 3 months; 6. History of myocardial infarction within 3 months; 7. History of percutaneous transluminal coronary angioplasty within 3 months; 8. History of permanent pacemaker implantation, heart valve placement, pulmonary vein stent implantation, or left atrial appendage occlusion. 9. Hypertrophic cardiomyopathy; 10. Left atrial anteroposterior diameter > 55 mm; 11. Left ventricular ejection fraction < 35%; 12. Left atrial thrombosis; 13. Atrial myxoma; 14. Patients with diaphragmatic paralysis; 15. Lactating, pregnant or planning or potential pregnant women; 16. Mental disorder or history of mental illness and inability to cooperate autonomously ; 17. Expected lifetime <12 months; 18. Patients participating in other interventional clinical investigations; 19. Not suitable for inclusion in the clinical investigation in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate at 12 months;Incidence of MAE(major adverse events); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success rate at 12 months;Acute success rate;Incidence of AE;Incidence of SAE;Incidence of Device Defects;Product Performance Evaluation; | — |
Countries
China
Contacts
Public ContactZhou Shenghua
The Second Xiangya Hospital of Central South University
Outcome results
None listed