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

NCT06039722 | Completed

• 1 other identifier: PMTCT2022001
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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. 1.Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
2. 2.Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
3. 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.
4. 4.The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
5. 5.Device performance evaluation;
6. 6.The occurrence of death, stroke, or transient ischemic attack;
7. 7.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;
8. 8.Clinically significant vital signs and related examinations;
9. 9.The occurrence of other adverse events and serious adverse events during the trial period.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Pulse Field Ablation Catheter

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• numer of cases of the the occurrence of hospitalization or emergency treatment

  Between 0 months and 12 months after ablation

• Device performance evaluation

  surgery period

Study Arms (1)

experimental group

EXPERIMENTAL

Each subject underwent pulse ablation catheter ablation

Device: Pulse ablation catheter

Interventions

Pulse ablation catheter DEVICE

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

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following conditions to be enrolled:
• to 80 years of age, gender is not limited
• Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
• Patients who were to undergo catheter ablation of atrial fibrillation
• Those who agreed to participate in this study and voluntarily signed the informed consent form

You may not qualify if:

• Subjects were excluded if they met one of the following conditions:
• Patients who have had ablation for atrial fibrillation
• Patients with left ventricular ejection fraction (LVEF) \<35%.
• Patients with an anteroposterior diameter of the left atrium (echocardiography) \>50 mm
• Preoperative detection of a definite thrombus in the left atrium
• Patients with cardiac function class (NYHA) III-IV
• Patients with second-degree (type II) or third-degree atrioventricular block
• 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)
• Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
• Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
• Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
• Patients who need to undergo left atrial appendage closure in the same surgery
• 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
• Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
• Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis

Sponsors & Collaborators

• Shenzhen Pulsecare Medical Technology Co., Ltd.: lead

Study Sites (1)

the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• Xie S, Lai H, Jia F, Zhang Z, Wang Y, Yin Y, Chen Q, Huang H, Liu Q, He J, Yang P, Wang J. High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial. Circ Arrhythm Electrophysiol. 2026 Feb 4:e014236. doi: 10.1161/CIRCEP.125.014236. Online ahead of print.

  PMID: 41636062 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: November 3, 2022
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: June 19, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)