3-Dimensional Mapping System: The PULSTAR Study

Shanghai Shangyang Medical Technology

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05618340

DHF-SYPL-003(A)

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Single group target value method

Experimental group

Description:

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.

Treatment:

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