3-Dimensional Mapping System: The PULSTAR Study

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT05618340
• Lead Sponsor: Shanghai Shangyang Medical Technology Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-26
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-16
• Primary Completion: 2024-03-27
• Study Completion: 2024-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of Treatment Success at 12-Month Post-Procedure	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.
Rate of Treatment Success at 3-Month Post-Procedure	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.
Rate of Treatment Success at 6-Month Post-Procedure	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.

Secondary Outcome Measures

Name	Time	Method
Immediate success rate: pulmonary vein isolation after ablation	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
Evaluation of Pulse Ablation Catheter	1 Day of surgery	Evaluation of catheter operation performance;Catheter ablation parameters
Evaluation of Pulse Ablation equipment	1 Day of surgery	System software operability;System operation stability;Hardware connection validity

Trial Locations

Locations (1)

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