3-Dimensional Mapping System: The PULSTAR II Study

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:

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.

Conditions

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

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

• Shanghai Shangyang Medical Technology Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-10

Primary Completion

2026-07-31

Completion

2026-09-30

Countries

• China

Study Locations