NCT07410962

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: SuZhou Sinus Medical Technologies Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation Fluttering

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-06
• Primary completion: 2026-11-30
• Completion: 2027-01-30
• First posted: 2026-02-13
• Last updated: 2026-02-13