NCT06039722Completed
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.
Source: ClinicalTrials.gov · Last updated 19 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 166 (actual)
- First submitted
- 10 Sept 2023
- Start date
- Nov 2022
- Primary completion date
- Aug 2024
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06039722
What you commit to
- Study type: Interventional
- Participants enrolled: 166
- From Nov 2022 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who need to undergo left atrial appendage closure in the same surgery
- Patients who have participated in a clinical trial of another drug or medical device within 3 months
Other illness
- Subjects were excluded if they met one of the following conditions:
- Patients with cardiac function class (NYHA) III-IV
- 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 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
- Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
- Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months
Lab values
- Patients with left ventricular ejection fraction (LVEF) \<35%.
Other
- Patients who have had ablation for atrial fibrillation
- Patients with an anteroposterior diameter of the left atrium (echocardiography) \>50 mm
- Preoperative detection of a definite thrombus in the left atrium
- Patients with second-degree (type II) or third-degree atrioventricular block
- 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 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
- Females who are pregnant or breastfeeding or who are planning to have children during the study period
- Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial
Who the study is looking for
- Subjects must meet all of the following conditions to be enrolled:
- 18 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital） Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
Related publications
- High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial.Circ Arrhythm Electrophysiol · 2026 · PMID 41636062
This page is information, not medical advice. Discuss any trial with your doctor.