3-Dimensional Mapping System: The PULSTAR II Study

Prospective, Multi-center, Single-arm Clinical Study of Nanosecond Pulsed Field Ablation System in the Treatment of Paroxysmal Atrial Fibrillation Under the Guidance of 3-Dimensional Mapping System

### Study Overview

• Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation."
• Sponsor The study is sponsored by a company called Shanghai Shangyang Medical Technology Co., Ltd.
• Trial Devices

The study will utilize two specialized devices:

1. **Nanosecond Pulsed Electric Field Ablation Device**: This device emits special electrical pulses to treat the heart.

2. **Magnetoelectric Dual-Positioning Petal Pulse Ablation Catheter**: This is a catheter that allows for precise navigation and treatment inside the heart.

   • Study Purpose The purpose of this study is to verify the safety and effectiveness of this new device in treating Paroxysmal Atrial Fibrillation, with the goal of enabling its widespread use in the future.
   • Study Design

This is a prospective, multicenter, single-arm target value study. This means:

• **Prospective**: The study looks forward in time, tracking patient outcomes.

• **Multicenter**: The study is conducted simultaneously across multiple hospitals.

• **Single-Arm Target Value**: All patients receive the same treatment, which is then compared against a predetermined target value.

  • Sample Size The study plans to enroll 149 patients.
  • Primary Endpoint The main goal of the study is to determine how many patients no longer experience atrial fibrillation, atrial flutter, or atrial tachycardia symptoms within 12 months after surgery. Specifically, it measures the proportion of patients who do not have arrhythmias lasting more than 30 seconds between 3 and 12 months post-surgery, as confirmed by electrocardiograms and other monitoring methods.
  • Secondary Endpoints

The study also includes several secondary objectives:

1. **Immediate Post-Surgical Ablation Success Rate**: To check how many patients have their atrial fibrillation successfully "isolated" immediately after surgery.

2. **Pulse Catheter Evaluation**: To assess the performance and ablation parameters of the catheter.

3. **Pulse Device Evaluation**: To evaluate the software operability, operational stability, and hardware connectivity of the device.

   • Safety Indicators

The study will also monitor the safety of the treatment, including:

1. **Primary Safety Endpoint**: The rate of adverse events occurring within 7 days after surgery.

2. **Secondary Safety Endpoint**: The incidence of device-related adverse events and serious adverse events.

   • Inclusion Criteria

Only patients who meet the following criteria can participate in the study:

1. Age between 18 and 75 years.

2. Diagnosed with Paroxysmal Atrial Fibrillation.

3. Recurrent episodes with noticeable symptoms.

4. Documented atrial fibrillation on an electrocardiogram or Holter monitor within the past year.

5. Poor response or intolerance to at least one standard antiarrhythmic medication.

6. Willingness to sign an informed consent form and comply with all study-related tests and procedures.

   • Exclusion Criteria

Patients with the following conditions cannot participate in the study:

1. Previous atrial fibrillation surgery.
2. Presence of left atrial thrombus.
3. Inability to use effective contraception during the 12-month study period.
4. Enlarged left atrium or other cardiac issues.
5. Severe systemic infections or other health problems.
6. Recent history of other serious diseases or surgeries.
7. Bleeding tendencies or other blood disorders.
8. Participation in other clinical trials within the past 3 months.

Scientific title： Prospective, multi-center, single-arm clinical study of nanosecond pulsed field ablation system in the treatment of paroxysmal atrial fibrillation under the guidance of three-dimensional cardiac electrophysiological mapping system Secondary sponsor：Shanghai Shangyang Medical Objectives of Study： The purpose of this study was to verify the safety and effectiveness of nanosecond pulsed electric field ablation system in paroxysmal atrial fibrillation and to provide evidence for product registration and clinical application.

Description for medicine or protocol of treatment in detail： The purpose of this study was to verify the safety and effectiveness of nanosecond pulsed electric field ablation system in paroxysmal atrial fibrillation and to provide evidence for product registration and clinical application. This is a prospective, multicenter and single-group target value study. All subjects were treated with paroxysmal atrial fibrillation using the test products provided in this protocol. The test results of the main indicators were statistically compared with the widely recognized standard of professional medicine -- the target value. If the bilateral 95% confidence interval of the test results was not lower than the target value, the test results could be considered to be up to standard.

Inclusion criteria

1. 18 years of age ≤75 years of age
2. The clinical diagnosis was paroxysmal atrial fibrillation
3. The disease recurred and the symptoms were obvious before enrollment
4. Atrial fibrillation was recorded by body surface electrocardiogram or by dynamic electrocardiogram (including single-lead electrocardiograph) for ≥30 s within 1 year before admission;
5. Ineffective or intolerance after treatment with at least one Class I or III antiarrhythmic drug
6. Fully understand the treatment plan, and voluntarily sign informed consent, willing to carry out the examination, surgery and follow-up required by the plan.

Exclusion criteria：

1) Patients who had undergone surgery for atrial fibrillation 2) Left atrial thrombus 3) Patients of childbearing age who could not take effective contraceptive measures during the 12 months after enrollment 4) Anterior and posterior diameter of left atrium ≥50mm 5) Left ventricular ejection fraction (LVEF) ≤40% 6) Atrial fibrillation caused by hyperthyroidism or non-cardiac causes 7) Past atrial septal repair or atrial myxoma 8) Carry active implants (such as pacemakers, ICDs, etc.) 9) NYHA Grade ⅲ-ⅳ cardiac function 10) Patients with definite cerebrovascular diseases within the last 6 months (including cerebral hemorrhage, stroke, and short stroke) Transient ischemic attack) 11) Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventricular otomy) 12) Acute or severe systemic infection 13) Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases, which researchers believe may interfere with the treatment, evaluation and compliance of this trial 14) Patients with obvious bleeding tendency, hypercoagulability and serious blood system diseases 15) Patients who had participated or were participating in other clinical trials within the 3 months prior to enrollment 16) Patients with other conditions deemed inappropriate by the investigator to participate in this study.

Primary indicator：Treatment success rate within 12 months after surgery

Measure method：Ecg, Holter, or equivalent heart rate monitoring (including single-lead ECG) without class I/III antiarrhythmic drugs during follow-up from 3 months (post-gap period) to 12 months after surgery.

Measure time point of outcome：Follow up at 3,6,12 month.

Secondary indicator:1)Success rate of immediate ablation Measure method：The proportion of the number of subjects electrically isolated for each atrial fibrillation patient to the total number enrolled after surgery. The verification method was to wait for 20 minutes after successful pulmonary vein isolation, and then confirm pulmonary vein block again.

Secondary indicator 2） Pulse catheter evaluation: Evaluation of catheter operation performance and catheter ablation parameters

Secondary indicator 3） Pulse equipment evaluation:System software operability, system running stability

Primary safety endpoint Measure method：Incidence of early onset (within 7 days after ablation) adverse events

Secondary safety endpoint The incidence of adverse events caused by study device The incidence of serious adverse events caused by study device

Expected Duration The overall duration of the clinical trial includes all processes such as ethical approval meetings and subsequent rectifications at all trial hospitals, signing of the clinical trial agreement and filing, study initiation, patient enrollment, electrocardiogram (ECG) testing of participants, collection and statistical analysis of trial data, and drafting of the summary report. The expected duration is set at 3 years.

Visit Duration The duration of each visit is 12 months.

Inclusion Criteria:

1. 18 years of age ≤75 years of age
2. The clinical diagnosis was paroxysmal atrial fibrillation
3. The disease recurred and the symptoms were obvious before enrollment
4. Atrial fibrillation was recorded by body surface electrocardiogram or by dynamic electrocardiogram (including single-lead electrocardiograph) for ≥30 s within 1 year before admission;
5. Ineffective or intolerance after treatment with at least one Class I or III antiarrhythmic drug
6. Fully understand the treatment plan, and voluntarily sign informed consent, willing to carry out the examination, surgery and follow-up required by the plan.

Exclusion Criteria:

1) Patients who had undergone surgery for atrial fibrillation 2) Left atrial thrombus 3) Patients of childbearing age who could not take effective contraceptive measures during the 12 months after enrollment 4) Anterior and posterior diameter of left atrium ≥50mm 5) Left ventricular ejection fraction (LVEF) ≤40% 6) Atrial fibrillation caused by hyperthyroidism or non-cardiac causes 7) Past atrial septal repair or atrial myxoma 8) Carry active implants (such as pacemakers, ICDs, etc.) 9) NYHA Grade ⅲ-ⅳ cardiac function 10) Patients with definite cerebrovascular diseases within the last 6 months (including cerebral hemorrhage, stroke, and short stroke) Transient ischemic attack) 11) Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventricular otomy) 12) Acute or severe systemic infection 13) Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases, which researchers believe may interfere with the treatment, evaluation and compliance of this trial 14) Patients with obvious bleeding tendency, hypercoagulability and serious blood system diseases 15) Patients who had participated or were participating in other clinical trials within the 3 months prior to enrollment 16) Patients with other conditions deemed inappropriate by the investigator to participate in this study.