Drug refractory, recurrent, symptomatic, persistent atrial fibrillation
Conditions
Interventions
test team:Pulse ablation surgery for persistent atrial fibrillation
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 ( including 75 ) years old, male and female are not limited. 2. Diagnosed as symptomatic persistent atrial fibrillation. Patients with atrial fibrillation duration >= 7 days or a history of persistent atrial fibrillation were recorded, and then any of the following conditions were met : 1 ) A dynamic electrocardiogram record within 365 days before the enrollment date was a full-course atrial fibrillation. 2 ) Within 365 days before the enrollment date, two electrocardiograms ( ECGs ) with a date interval of more than 7 days showed atrial fibrillation. 3. After at least one type I or type ? AAD treatment, the effect is not good, or can not tolerate type ? or type ? AAD 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. Paroxysmal atrial fibrillation; 2. Atrial fibrillation caused by electrolyte imbalance, thyroid disease, reversible or non-cardiac causes; 3. Retreated patients after rapid atrial arrhythmia ablation; 4. Patients with sustained ventricular tachycardia or ventricular fibrillation; 5. Left atrial diameter > 55mm; 6. Previous left atrial ablation or surgery ( including left atrial appendage occlusion ); 7. 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 ); 8. There is a history of anticoagulant contraindications, blood coagulation or bleeding abnormalities. 9. Severe lung disease: severe pulmonary hypertension or any lung disease involving severe dyspnea such as abnormal blood gas. 10. Any cardiac surgery, implant or condition listed below: prosthetic valve, congestive heart failure of NYHA class III or IV, or left ventricular ejection fraction ( LVEF ) < 40 %, atrial septal or ventricular septal defect occlusion, atrial myxoma, left atrial appendage device or occlusion. 11. Any of the following medical histories occurred three months before surgery: myocardial infarction, unstable angina, percutaneous coronary intervention, cardiac surgery, including coronary artery bypass grafting, hospitalization for acute heart failure, pericarditis. 12. Any of the following medical history: cerebral infarction, transient ischemic attack, any documented thromboembolic event within 3 months before surgery. 13. History of malignant tumor or life expectancy < 12 months. 14. Mental disorders or a history of mental illness and inability to cooperate independently. 15. Suckling, pregnancy and planned or possible pregnancy women. 16. Acute or severe systemic infection, abnormal liver and kidney function; 17. 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 |
|---|---|
| Incidence of major adverse events ( within 7 days after surgery );Treatment success rate at 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events ( within 7 days after surgery ), and adverse events related to test equipment.;Evaluation of left atrial three-dimensional modeling and electroanatomic mapping;Immediate success rate of surgery;Surgical and related indicators;Product performance evaluation; | — |
Countries
China
Contacts
Public ContactChenyang Jiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed