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Completed

NCT Number: NCT05618340

3-Dimensional Mapping System: The PULSTAR Study

The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.

The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province

Shenyang, Liaoning, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 and ≤75 years of age.
  • Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment.
  • Clinical diagnosis of paroxysmal atrial fibrillation.
  • Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.
  • Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.

Exclusion criteria

  • Patients who have undergone left atrial surgery
  • Left atrial thrombosis
  • Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment
  • Anterior and posterior left atrial diameter ≥ 50 mm
  • Left ventricular ejection fraction (LVEF) ≤ 40%
  • Previous atrial septal repair or atrial mucinous tumor
  • Active implants (e.g. pacemakers, ICDs, etc.) in the body
  • NYHA class III-IV cardiac function [Appendix 1]
  • Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
  • Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
  • Those with acute or severe systemic infections
  • Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
  • Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
  • Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
  • Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Treatment and study plan

Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter

Device

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 circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation.

Primary outcomes

  1. Rate of Treatment Success at 3-Month Post-Procedure

    Time frame: Refers to the postoperative phase (blank) after 3 months postoperatively

    Refers to the postoperative phase (blank) after 3 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.

  2. Rate of Treatment Success at 6-Month Post-Procedure

    Time frame: Refers to the postoperative phase (blank) after 6 months postoperatively

    Refers to the postoperative phase (blank) after 6 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.

  3. Rate of Treatment Success at 12-Month Post-Procedure

    Time frame: Refers to the postoperative phase (blank) after 12 months postoperatively

    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.

Secondary outcomes

  1. Immediate success rate: pulmonary vein isolation after ablation

    Time frame: 1 Day of surgery

    Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. Validation was a 20-minute wait after successful electrical isolation of the pulmonary vein, followed by reconfirmation of pulmonary vein block

  2. Evaluation of Pulse Ablation Catheter

    Time frame: 1 Day of surgery

    Evaluation of catheter operation performance;Catheter ablation parameters

  3. Evaluation of Pulse Ablation equipment

    Time frame: 1 Day of surgery

    System software operability;System operation stability;Hardware connection validity

Other outcomes

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

    Time frame: Within 7 days after the surgery

    The primary safety endpoint

  2. Incidence of adverse events and serious adverse events associated with the study device

    Time frame: Within 12 months after sign the informed consent form

    Secondary Security Endpoints

Sponsors and collaborators

Lead sponsor

Shanghai Shangyang Medical Technology Co., Ltd.

Industry

Registry information

Official study title

Pulsed Field Ablation Paroxysmal Atrial Fibrillation Using a Novel Spiral Catheter Integrated With a 3-Dimensional Mapping System: The PULSTAR Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2022
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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