Safety and Initial Efficacy Study of a Cardiac Surgical Pulsed Field Ablation System for the Treatment of Atrial Fibrillation

This study is a prospective, single-center, single-arm, non-randomized study focused on safety and preliminary efficacy, aiming to evaluate the safety and preliminary efficacy of a cardiac pulsed field ablation device and a single-use cardiac surgical pulsed field ablation electrode for elective cardiovascular surgery combined with Cox-maze IV surgery as a reference treatment for atrial fibrillation. Adult subjects meeting the clinical indications for concomitant cardiac surgery will undergo the Cox-maze IV procedure as a reference, which includes isolation of the left and right pulmonary veins and a series of ablation lines to create a box isolation area on the posterior free wall of the left atrium, as well as linear ablation on the mitral annulus and left atrial appendage. On the right side of the heart, ablation will be performed on the anterior free wall of the right atrium, right atrial appendage, and from the right atrial appendage to the tricuspid annulus, with immediate verification of effective pulmonary vein isolation. After the completion of surgical ablation, all subjects will be followed up in the hospital before discharge, and at 30±7 days, 90±14 days, and 180±30 days postoperatively. The blanking period refers to a specified 90-day observation period after surgery during which events are not included in the secondary efficacy evaluation. All subjects will undergo assessment based on electrocardiographic records at 180 days following surgical ablation to evaluate the success of the procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation Fluttering
• Intervention / Treatment: Device: Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zhangxue; Phone Number: 86+13122163513; Email: zhangxue@sinusmedtech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects aged ≥ 18 years and ≤ 80 years;
• Subjects are willing and able to sign the informed consent form to receive study treatment, including surgical atrial fibrillation ablation, and complete the follow-up specified in the clinical study protocol;
• Subjects with a history, electrocardiogram, or Holter ECG confirming paroxysmal atrial fibrillation, persistent atrial fibrillation (lasting more than seven days, or less than seven days but requiring drug or electrical cardioversion), or long-standing persistent atrial fibrillation (lasting more than one year);
• Left ventricular ejection fraction > 30% (determined by echocardiography or cardiac catheterization within 60 days prior to enrollment, as recorded in the patient's medical history);
• Subjects scheduled to undergo open-heart surgery, including one or more of the following cardiac surgeries performed under direct vision: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, and coronary artery bypass grafting;
• Subjects with an expected survival of ≥ 1 year.

Exclusion Criteria:

• Subjects with implanted electronic medical devices (such as pacemakers, ICDs, or CRT) or left atrial appendage devices;
• Subjects with artificial heart valves;
• Subjects with atrial fibrillation only, without indications for coronary artery bypass grafting (CABG) and/or valve surgery;
• History of previous atrial fibrillation ablation, atrioventricular (AV) node ablation, or Maze procedure;
• History of previous cardiac surgery (reoperation);
• Wolff-Parkinson-White (WPW) syndrome or other supraventricular arrhythmias, AV nodal reentry, ventricular arrhythmias requiring antiarrhythmic drug treatment, or uncontrolled bradyarrhythmias (sinus bradycardia, junctional rhythm, ventricular escape rhythm, sinus arrest, sinoatrial block, second-degree AV block, third-degree AV block, and sick sinus syndrome).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode

Device: Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode; Subjects will undergo ablation with reference to the Cox-maze IV surgical approach, using a cardiac pulsed field ablation device and a disposable cardiac surgical pulsed field ablation electrode. The study period is expected to be 195 days, with a screening period of up to 14 days, a treatment period of 1 day, and a follow-up period of 180 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: The incidence of acute major adverse events (MAE) occurring within 30 days after ablation	Including death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or serious bleeding (bleeding requiring transfusion of more than 2 units of blood and surgical intervention).	30 days after ablation
Efficacy: The rate of freedom from atrial fibrillation events at 180 days post-ablation without the use of antiarrhythmic drugs (AADs)	defined as no recorded atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) during the efficacy evaluation period.	180 days after ablation

Collaborators and Investigators

• Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd
• Collaborators: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 6, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B2025-844R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No