Drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation
Conditions
Interventions
Mapping and pulsed ablation group:Mapping and pulse ablation
Sponsors
Beijing Anzhen Hospital. Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years,regardless of gender. 2. Diagnosed with symptomatic paroxysmal atrial fibrillationParoxysmal AF.Symptomatic paroxysmal atrial fibrillation is defined as episodes that terminate spontaneously within 7 days of onset.Relevant data recorded within one year prior to enrollment through electrocardiogramECG,Holter monitoring,implantable devices,or similar devices. 3. Patients who have shown poor response to treatment with at least one Class I or Class III antiarrhythmic drugAADor are intolerant to treatment with Class I or Class III AAD. 4. Willing to participate in the trial,undergo the required follow-up as stipulated in the protocol,and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Persistent atrial fibrillation (continuous atrial fibrillation lasting >7 days) 2. Atrial fibrillation caused by electrolyte imbalance, thyroid disease, reversible or non-cardiac reasons 3. Patients requiring re-treatment after ablation of rapid atrial arrhythmias 4. Clear coexistence of atrial flutter or atypical atrial flutter 5. Left atrial diameter (measured by echocardiography) > 47mm 6. Previous left atrial ablation or surgical procedures (including left atrial appendage occlusion) 7. Carrying permanent pacemakers, biventricular pacemakers, loop recorders/implantable cardiac monitors (ICM), or any type of implantable cardiac defibrillators (with or without biventricular pacing function) 8. Presence of contraindications to anticoagulation, history of blood clotting or bleeding disorders 9. Severe pulmonary diseases, pulmonary hypertension, or any pulmonary diseases involving blood gas abnormalities and causing severe dyspnea 10. Any of the following cardiac surgeries, implants, or conditions: (1) Artificial valves (2) NYHA Class III or IV, congestive heart failure, or left ventricular ejection fraction (LVEF) < 40% (3) Atrial or ventricular septal defect closure (4) Atrial myxoma, left atrial appendage device or occlusion 11. Any of the following histories within 3 months before surgery: (1) Myocardial infarction (2) Unstable angina (3) Percutaneous coronary intervention (4) Cardiac surgery, including coronary artery bypass grafting (5) Hospitalization for heart failure (6) Pericarditis 12. Any of the following histories within 6 months before surgery: (1) Cerebral infarction, transient ischemic attack (2) Documented thromboembolic events (such as transesophageal echocardiography) 13. History of malignant tumors or expected survival < 12 months 14. Mental disorders or a history of mental illness and inability to cooperate independently 15. Women in lactation, pregnancy, or planning or possibly becoming pregnant 16. Acute or severe systemic infection, significant liver or kidney function abnormalities 17. Currently participating in other interventional clinical trials, or judged by the investigator as unsuitable for inclusion in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events, and adverse events related to test instruments occurred in the mapping system, the mapping catheter, and the body surface electrode;Treatment success rate of ablation equipment and catheter 12 months after surgery (3 months after surgery is a blank period);Incidence of major adverse events of ablation devices and ablation catheters (within 7 days after surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate of mapping system, mapping catheter and body surface electrode surgery;Accuracy of mapping system, mapping catheter and surface electrode model;Performance evaluation of mapping system, mapping catheter and body surface electrode products;Mapping system, mapping catheter, body surface electrode operation and related indexes;Immediate success rate of ablation equipment and catheter surgery;Performance evaluation of ablation equipment and ablation catheter products;Ablation equipment, ablation catheter surgery and ablation related indexes;Adverse events of ablation equipment, ablation catheter, serious adverse events (within 7 days after surgery), and adverse events related to test instruments; | — |
Countries
China
Contacts
Public ContactCaihua Sang
Beijing Anzhen Hospital. Capital Medical University
Outcome results
None listed