Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China

Paroxysmal Atrial Fibrillation Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06039722
• Other study ID #: PMTCT2022001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: August 17, 2024

Study information

• Verified date: September 2023
• Source: Shenzhen Pulsecare Medical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 166
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Pulse ablation catheter
Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Pulsecare Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	After surgery 20 minutes later
Primary	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%	Between 3 months and 12 months after ablation
Secondary	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;	Between 0 months and 12 months after ablation
Secondary	Device performance evaluation	Device defects of the clinical trial equipment	surgery period