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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
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).
Time frame: 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.
Time frame: 180 days after ablation
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