Paroxysmal atrial fibrillation
Conditions
Interventions
Radiofrequency ablation groupe:The conventional radiofrequency ablation protocol for atrial fibrillation was used with THERMOCOOL SMARTTOUCH SF disposable radiofrequency ablation pressure .catheter (B
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 Union Hospital of Jilin University (defined as previous paroxysmal AF lasting at least 30 seconds recorded by 12-lead electrocardiogram, Holter monitoring, or >=2 episodes of AF within 6 months after enrollment) 2. Patients who were 18 years of age or older and 75 years of age or younger on the day of enrollment 3. Patients who are willing and able to provide written informed consent to undergo the study procedures and who are willing to participate in all examinations and follow-up and tests related to this clinical study.
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation meets any of the following conditions: a. Duration (depending on diagnosis or duration >7 days) b. Secondary to electrolyte imbalance, thyroid disease, alcoholism, or other reversible/non-cardiac causes c. There have been at least 3 cardioversion treatments in the past 12 months 2.Any atrial condition that meets the following conditions: a. Anterior and posterior diameter of left atrium (LA) >= 5.5cm (by MRI, CT or TTE) b. Any previous atrial endocardial or epicardial ablation (except right isthmus ablation or right supraventricular tachycardia ablation) c. Any previous atrial surgery d. intra-atrial septal patch or atrial shunt e. atrial myxoma f. Presence of LA thrombus g. Present with left auricular implant or have undergone surgical ligation of left auricular h. any clinically significant pulmonary venous abnormalities 3.At any time, there is a history of one or more of the following cardiovascular procedures, cardiac implants, or other related medical history: a. Persistent ventricular tachycardia ventricular fibrillation b. Valvular diseases with significant effects on hemodynamics: a) Symptomatic valvular disease b) valvular disease that causes or exacerbates congestive heart failure c) Aortic stenosis valve area 20 mm Hg d) mitral stenosis valve area 5 mm Hg e) Aortic or mitral regurgitation associated with left ventricular function or hemodynamic abnormalities c. Hypertrophic cardiomyopathy d. History of implantation of any artificial heart valve, ring, or repair, including transcatheter balloon aortic valvuloplasty e. History of implantation of a pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device f. The presence of an inferior vena cava (IVC) filter, or known inability to obtain vascular access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormalities 4.Any of the following conditions exist: a. Appear at baseline: a) NYHA Classification III/IV b) Left ventricular ejection fraction (LVEF) 160 mmHg or DBP > 95 mmHg for two blood pressure measurements at baseline assessment) e) Symptomatic resting bradycardia f) The presence of implanted ECG monitors b. Within the first 3 months of enrollment: a) Myocardial infarction b) Unstable angina pectoris c) Percutaneous coronary intervention d) hospitalization for heart failure e) Receiving amiodarone f) pericarditis or symptomatic pericardial effusion g) Gastrointestinal bleeding c. Within 6 months prior to enrollment: a) Cardiac surgery b) Stroke, TIA, or intracranial hemorrhage c) Any thromboembolic events d) Carotid stenting or endarterectomy 5.A diagnosis of coagulation dysfunction or the presence of significant bleeding tendencies 6.There are contraindications or refusal to use anticoagulants 7.Patients who did not receive anticoagulation therapy for at least 3 weeks prior to ablation 8.Contraindications with CT or MRI are present 9.Patients who are allergic to contrast agents and cannot be controlled by preoperative medication 10.Women of childbearing age who are pregnant or breastfeeding 11.Medical conditions that would prevent participation in a study, interfere with evaluation or treatment, significantly increase the risk of participation in a study, or modify the resulting data or its interpretation, including but
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute surgical success, defined as electrical isolation of all pulmonary veins maintained 20 minutes after completion of pulmonary vein isolation;Successful chronic surgery (within 12 months after surgery) : a. Avoid pulmonary vein reisolation using non-experimental instruments b. No detectable occurrence of AF, AFL, or AT after the gap period c. No electrical cardioversion caused by AF, AFL or AT d. No type I or III antiarrhythmic drugs are required to treat AF, AFL or AT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total operating time;Catheter retention time;Total ablation time;Intraoperative fluoroscopy time;Percentage of patients with no recurrence of atrial arrhythmias at 3 months follow-up; | — |
Countries
China
Contacts
Public ContactYuquan He
The China-Japan Union Hospital of Jilin University
Outcome results
None listed