Paroxysmal Atrial Fibrillation
Conditions
Interventions
Experimental group:Multi-channel pulsed electric field ablation instrument combined with controllable bending annular pulsed ablation catheter for paroxysmal atrial fibrillation
Sponsors
Beijing Chao-Yang Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 years old <=age<=80 years old, regardless of gender. 2 patients with paroxysmal atrial fibrillation confirmed by electrocardiogram or clinically diagnosed. 3. Patients planning to receive catheter ablation of atrial fibrillation. 4. Those who agree to participate in this study and sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1.Patients who have undergone atrial fibrillation ablation surgery. 2.Those with left ventricular ejection fraction (LVEF) 55 mm. 4.Those found of definite thrombus in left atrium before surgery. 5.Patients with cardiac functional grading (NYHA) of grade ?-?. 6.Patients with second-degree (type II) or third-degree atrioventricular block. 7.Patients with obvious congenital heart defects (including atrial septal defect or severe pulmonary vein stenosis, but excluding patent foramen ovale). 8.Patients implanted with artificial valve. 9.Patients diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease and myxoma. 10.Patients who need to receive left atrial appendage occlusion during this surgery. 11.Patients with systemic active infection who are judged by the researcher to be unable to undergo interventional therapy. 12.Patients with renal failure who have obvious bleeding tendency and cannot be operated or are undergoing hemodialysis. 13. Patients once subject to myocardial infarction in the past 3 months or having received any interventional/open cardiac surgery (coronary angiography excluded). 14.Patient once subject to stroke (asymptomatic stroke excluded) or transient ischemic attack in the past month. 15.Patients with obvious interventional therapy contraindications and judged by the investigators as unable to receive ablation. 16.Pregnant or lactating women or those who have family planning during the study period. 17.Patients who have participated in clinical trials of other drugs or medical devices in the past three months. 18.Patients inappropriate for this clinical trial, as considered by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of treatment 12 months after surgery;Instant success rate of surgery;Device performance evaluation for pulsed ablation catheter.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital admission or emergency treatment due to atrial tachycardia symptoms during postoperative 6-month and 12-month follow-up.;Device performance evaluation for pulsed field ablation generator.;Hospital admission or emergency treatment due to atrial tachycardia symptoms during postoperative 6-month and 12-month follow-up.; | — |
Countries
China
Contacts
Public ContactXingpeng Liu
Beijing Chao-Yang Hospital ,Capital Medical University
Outcome results
None listed