Paroxysmal atrial fibrillation
Conditions
Interventions
Sponsors
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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 paroxysmal atrial fibrillation 3) Failed at least one antiarrhythmic drug (AAD), or intolerable or contraindicated to the AAD 4) Willing to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients with previous ablation of atrial fibrillation 2) Concomitant with ventricular tachycardia 3) Concomitant with paroxysmal supraventricular tachycardia 4) Patients with implanted permanent pacemaker, prosthetic heart valve, pulmonary vein stents, or left atrial appendage occlusion 5) Patients with cardiac surgery 6) Hemorrhagic stroke within 6 months 7) Transient ischemic attack or ischemic stroke within 3 months 8) History of myocardial infarction or percutaneous transluminal coronary angioplasty within 3 months 9) Hypertrophic cardiomyopathy 10) Rheumatic heart disease 11) Left atrial anteroposterior diameter > 50 mm 12) Left atrial myxoma 13) Left ventricular ejection fraction < 40%, or New York Heart Association (NYHA) Class III/IV 14) Left atrial thrombosis 15) Patients with diaphragmatic paralysis 16) Lactating, pregnant or planning or potential pregnant women 17) Mental disorder or history of mental illness and inability to cooperate autonomously 18) Expected lifetime <12 months 19) Patients participating in other interventional clinical investigations 20) 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 |
|---|---|
| Acute success rate;Clinical success rate at 12 months;Incidence of AE;Incidence of SAE;Incidence of Device Defects;Product Performance Evaluation; | — |
Countries
China
Contacts
Public ContactYao Yan
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed