3-Dimensional Mapping System: The PULSTAR Study

NCT05618340 | Completed

• 1 other identifier: DHF-SYPL-003(A)
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

pulse field ablation; PFA; Paroxysmal Atrial Fibrillation; PAF

Outcome Measures

Primary Outcomes (3)

• Rate of Treatment Success at 3-Month Post-Procedure

  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.

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

• Rate of Treatment Success at 6-Month Post-Procedure

  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.

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

• Rate of Treatment Success at 12-Month Post-Procedure

  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

Secondary Outcomes (3)

• Immediate success rate: pulmonary vein isolation after ablation

  1 Day of surgery

• Evaluation of Pulse Ablation Catheter

  1 Day of surgery

• Evaluation of Pulse Ablation equipment

  1 Day of surgery

Other Outcomes (2)

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

  Within 7 days after the surgery

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

  Within 12 months after sign the informed consent form

Study Arms (1)

Single group target value method

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.

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

Interventions

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.

Single group target value method

Eligibility Criteria

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

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Shenyang, Liaoning, 110016, 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: November 6, 2022
• First Posted: November 16, 2022
• Study Start: September 26, 2022
• Primary Completion: March 27, 2024
• Study Completion: June 1, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)