NCT06039722

Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation

Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Shenzhen Pulsecare Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulse ablation catheter	Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2023-09-15
• Last updated: 2025-06-19

Locations

1 site across 1 country: China