This study is expected to include 166 subjects and Conducted at 11 research centers;The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes: 1. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. 2. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100% 3. Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100% Secondary evaluation indexes: 1. The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery; 2. Device performance evaluation; Safety evaluation indexes: 1. The occurrence of death, stroke, or transient ischemic attack; 2. The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc; 3. Clinically significant vital signs and related examinations; 4. The occurrence of other adverse events and serious adverse events during the trial period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential
the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital)
Guangzhou, Guangdong, China
Immediate success rate of surgery
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
Time frame: After surgery 20 minutes later
Treatment success rate
Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Time frame: Between 3 months and 12 months after ablation
numer of cases of the the occurrence of hospitalization or emergency treatment
The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
Time frame: Between 0 months and 12 months after ablation
Device performance evaluation
Device defects of the clinical trial equipment
Time frame: surgery period
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