Paroxysmal atrial fibrillation
Conditions
Sponsors
The China-Japan Union Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with symptomatic paroxysmal atrial fibrillation (AF) in China-Japan Friendship Hospital of Jilin University (defined as: previous paroxysmal atrial fibrillation lasting at least 30 seconds recorded by 12-lead ECG, Holter detection and other equipment or >=2 episodes of atrial fibrillation within 6 months after enrollment); 2. Patients with >=18 years old and <=75 years old on the day of enrollment; 3. Patients who are willing and able to provide informed consent to undergo study procedures and who are willing to participate in all examinations and follow-up visits and tests related to this clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients have used amiodarone within 3 months before enrollment; 2. The patient's atrial fibrillation meets any of the following conditions: (1) persistent (> 7 days depending on diagnosis or duration); (2) secondary to electrolyte imbalance, thyroid disease, alcoholism, or other reversible/non-cardiac causes; (3) >= 3 cardioversion treatments in the past 12 months; 3. The following conditions were found by imaging examination within 3 months before the enrollment of the patient: (1) Left atrium anteroposterior diameter >= 5.0 cm recorded by transthoracic echocardiography (TTE) or computed tomography (CT); (2) Left ventricular ejection fraction recorded by TTE 20 mm Hg; d) Mitral stenosis, valve area 5 mm Hg; e) aortic or mitral regurgitation associated with left ventricular function or hemodynamic abnormalities; (3) History of previous prosthetic heart valve implantation; (4) NYHA Class III or IV chronic heart failure; (5) Previous ablation or surgery due to AF; (6) Atrial septal defect or ventricular septal defect; (7) Atrial myxoma; (8) Previous left atrial appendage occlusion or surgical left atrial appendage clipping surgery; (9) Previous implantation of pacemaker, ICD or CRT; (10) the presence of symptomatic hypotension; (11) bradycardia; (12) History of pericarditis; (13) History of rheumatic fever; 5. Occurrence of any of the following within 3 months of patient enrollment: (1) myocardial infarction; (2) unstable angina; (3) percutaneous coronary intervention; (4) cardiac surgery, including coronary artery bypass grafting; (5) Hospitalization due to heart failure; (6) stroke or TIA; (7) clinically significant bleeding events; (8) pericarditis or pericardial effusion; (9) Left atrial thrombosis; 6. The patient has a hypercoagulable state of blood or bleeding tendency that will affect the surgical procedure; 7. Patient has contraindications to systemic anticoagulants or is unwilling to use anticoagulants; 8. The patient has contraindications to CT or MRI; 9. The patient is allergic to contrast media and is not controlled by preoperative medication; 10. Women of childbearing potential who are pregnant or breastfeeding; 11. Serious or untreated medical conditions that would prevent participation in the study, interfere with evaluation or treatment, confound data, including but not limited to: (1) Previous history of solid organ or blood transplantation, or currently undergoing organ transplant evaluation; (2) The patient has severe pulmonary disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or severe dyspnea; (3) The patient has chronic renal insufficiency <60mL/min/1.73m^2, or has a history of renal dialysis or kidney transplantation; (4) Have active malignancy or have a history of cancer treatment; (5) Clinically significant digestive tract problems involving the esophagus and stomach; (6) clinically significant infection; (7) Life expectancy of less than one year; 12. Clinically significant abnormalities in psychological conditions that, in the opinio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary vein isolation rate measured by invasive electrophysiological re-mapping three months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with acute pulmonary vein isolation;Total surgical time, including the time from the first femoral vein puncture to the final catheter withdrawal;Catheter indwelling time (defined as the time between insertion of the ablation catheter into the left atrium and withdrawal of the ablation catheter);Total ablation time (defined as the cumulative time for ablation with PFA application);Intraoperative fluoroscopy time;Percentage of patients with no recurrence of atrial arrhythmia after 12 months of follow-up (any episode of atrial tachyarrhythmia recorded on a holter or 12-lead ECG with a duration of >30 s is considered a recurrence); | — |
Countries
China
Contacts
Public ContactYuquan He
The China-Japan Union Hospital of Jilin University
Outcome results
None listed