3-Dimensional Mapping System: The PULSTAR II Study

NCT07586176 | Active Not Recruiting

• 1 other identifier: DHF-SYNE-037(A)
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

\### 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:
• \*\*Nanosecond Pulsed Electric Field Ablation Device\*\*: This device emits special electrical pulses to treat the heart.
• \*\*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:
• \*\*Immediate Post-Surgical Ablation Success Rate\*\*: To check how many patients have their atrial fibrillation successfully "isolated" immediately after surgery.
• \*\*Pulse Catheter Evaluation\*\*: To assess the performance and ablation parameters of the catheter.
• \*\*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:
• \*\*Primary Safety Endpoint\*\*: The rate of adverse events occurring within 7 days after surgery.
• \*\*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:
• Age between 18 and 75 years.
• Diagnosed with Paroxysmal Atrial Fibrillation.
• Recurrent episodes with noticeable symptoms.
• Documented atrial fibrillation on an electrocardiogram or Holter monitor within the past year.
• Poor response or intolerance to at least one standard antiarrhythmic medication.
• 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:
• Previous atrial fibrillation surgery.
• Presence of left atrial thrombus.
• Inability to use effective contraception during the 12-month study period.
• Enlarged left atrium or other cardiac issues.
• Severe systemic infections or other health problems.
• Recent history of other serious diseases or surgeries.
• Bleeding tendencies or other blood disorders.
• Participation in other clinical trials within the past 3 months.

Conditions

Paroxysmal AF; Pulsed Field Ablation; Atrial Fibrillation (Paroxysmal)

Keywords

Atrial Fibrillation (Paroxysmal); Atrial Fibrillation; Nanosecond pulsed electric field ablation; Pulsed field; Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Treatment success rate within 12 months after ablation

  Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.

  Refers to the postoperative phase (blank) after 12 months postoperatively, follow up at 3,6,12 month

Secondary Outcomes (1)

• Immediate success rate: pulmonary vein isolation after ablation

  1 Day of ablation

Other Outcomes (2)

• The incidence of early onset (within 7 days of ablation) adverse events

  Within 7 days after the ablation

• Incidence of adverse events and serious adverse events associated with the study device

  Within 12 months after ablation

Study Arms (1)

Single group target value method Arm

EXPERIMENTAL

This trial is a prospective, multicenter, single-group target value method study. All subjects are treated uniformly with the pulse ablation system provided in this protocol for paroxysmal AF, and the test results for the main indicators are statistically compared with the target values, a widely accepted standard in professional medicine, and the test results are considered to be attained if the one-sided 95% confidence interval for the test results is not lower than the target values.

Procedure: Nanosecond pulsed electric field ablation system; Cardiac Pulsed Electric Field Ablation Catheter

Interventions

Nanosecond pulsed electric field ablation system; Cardiac Pulsed Electric Field Ablation Catheter PROCEDURE

Routinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance. Pulmonary vein-by-pulmonary vein ablation using a pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation.

Single group target value method Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Shanghai Shangyang Medical Technology Co., Ltd.: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

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
• Masking Details: Non-blind method
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial is a prospective, multicenter, single-group target value method study

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: October 10, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)