Clinical trial NCT06039722: Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Pulse Field Ablation Catheter
Lead sponsor: Shenzhen Pulsecare Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following conditions to be enrolled:

1. 18 to 80 years of age, gender is not limited
2. Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
3. Patients who were to undergo catheter ablation of atrial fibrillation
4. Those who agreed to participate in this study and voluntarily signed the informed consent form

Exclusion Criteria:

Subjects were excluded if they met one of the following conditions:

1. Patients who have had ablation for atrial fibrillation
2. Patients with left ventricular ejection fraction (LVEF) \<35%.
3. Patients with an anteroposterior diameter of the left atrium (echocardiography) \>50 mm
4. Preoperative detection of a definite thrombus in the left atrium
5. Patients with cardiac function class (NYHA) III-IV
6. Patients with second-degree (type II) or third-degree atrioventricular block
7. Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens)
8. Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
9. Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
10. Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
11. Patients who need to undergo left atrial appendage closure in the same surgery
12. Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia
13. Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
14. Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis
15. Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
16. Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months
17. Patients with significant contraindications to interventional procedures or with an expected survival of \<1 year who are judged by the investigator to be incapable of undergoing ablative procedures
18. Females who are pregnant or breastfeeding or who are planning to have children during the study period
19. Patients who have participated in a clinical trial of another drug or medical device within 3 months
20. Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial

Primary outcomes:
measure: Immediate success rate of surgery
timeFrame: After surgery 20 minutes later
measure: Treatment success rate
timeFrame: Between 3 months and 12 months after ablation
Secondary outcomes:
measure: numer of cases of the the occurrence of hospitalization or emergency treatment
timeFrame: Between 0 months and 12 months after ablation
measure: Device performance evaluation
timeFrame: surgery period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
state: Guangdong
Study officials:
References: