Drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
Conditions
Interventions
Test team:Atrial fibrillation pulse ablation
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 to 80 years old ( including 80 ), men and women are not limited; 2.Diagnosed as symptomatic paroxysmal atrial fibrillation ( PAF ). Symptomatic paroxysmal atrial fibrillation is defined as spontaneous termination within 7 days after spontaneous onset. The relevant data recorded by electrocardiogram, dynamic electrocardiogram, implantable instruments or similar instruments were recorded within 1 year before enrollment; 3.After antiarrhythmic drug treatment, the effect is not good, or can not tolerate antiarrhythmic drug treatment; 4.Are willing to participate in the trial and accept the follow-up requirements of the program and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1.Persistent atrial fibrillation ( continuous atrial fibrillation for more than 7 days ); 2.Atrial fibrillation caused by electrolyte imbalance, thyroid disease, reversible or non-cardiac causes; 3.Retreated patients after atrial tachyarrhythmia ablation; 4.Left atrial anteroposterior diameter ( echocardiography ) > 55mm; 5.Previous left atrial ablation or surgery ( including left atrial appendage occlusion ); 6.Carrying a permanent pacemaker, a biventricular pacemaker, a loop recorder / implantable cardiac monitor ( ICM ) or any type of implantable cardiac defibrillator ( with or without biventricular pacing ); 7.There is a history of anticoagulant contraindications, abnormal coagulation function or abnormal bleeding. 8.Severe lung disease : severe pulmonary hypertension or any lung disease involving severe dyspnea such as abnormal blood gas. 9.Any cardiac surgery, implant or disease listed below : prosthetic valve ; nYHA grade III or IV, or left ventricular ejection fraction ( LVEF ) < 40 % ; closure of atrial septal or ventricular septal defect ; atrial myxoma, left atrial appendage device or occlusion; 10.Any of the following medical history occurred 3 months before surgery : myocardial infarction ; unstable angina ; percutaneous coronary intervention ; cardiac surgery, including coronary artery bypass grafting ; heart failure hospitalization ; pericarditis; 11.Any of the following medical history occurred within 3 months before surgery : cerebral infarction, transient ischemic attack ; any recorded thromboembolic events; 12. History of malignant tumor or life expectancy < 12 months; 13. Mental disorders or a history of mental illness and inability to cooperate autonomously; 14. Pregnant women during lactation, pregnancy and 12 months after planned surgery; 15. acute or severe systemic infection, liver and kidney function significantly abnormal; 16. Is participating in other interventional clinical trials, or is judged by researchers to be unsuitable for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of treatment was 12 months after operation.;Incidence of major adverse events ( within 7 days after surgery ); | — |
Secondary
| Measure | Time frame |
|---|---|
| product performance evaluation;Surgery and related indicators ( modeling mapping time, skin-to-skin operation time, left atrial residence time, number of discharges, ablation time of each pulmonary vein isolation, total X-ray expos;Three-dimensional modeling of left atrium and evaluation of electroanatomic mapping;Immediate success rate of surgery;Adverse events, serious adverse events ( within 7 days after surgery ), test equipment related adverse events.; | — |
Countries
China
Contacts
Public ContactZhenning Nie
Zhongshan Hospital, Fudan University
Outcome results
None listed