This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this study aims to initially verify the safety and efficacy of the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
First, pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd), then, pulsed field ablation and mechanical closure of the left atrial appendage were achieved by E-SeaLATM(Hangzhou Dinova EP Technology Co., Ltd) implantation.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGFuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
RECRUITINGGeneral Hospital of Northern Theater Command
Shenyang, Liaoning, China
RECRUITINGTechnical success rate
Technical success means that the pulmonary vein and left atrial appendage(LAA) remain electrical isolation 20 minutes after ablation, and the per-device leaks≤ 3 mm after E-SeaLA LAA pulsed field ablation(PFA) occluder implantation.
Time frame: immediately after the procedure
The incidence of major adverse events (MAEs) related to devices or procedures 3 months after procedure
MAE includes death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrial esophageal fistula, severe vascular access complications, device migration, and device embolization.
Time frame: within 3 months after procedure
Ablation efficiency including total procedure time, catheter dwell time, total ablation time and total X-ray exposure time
Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), total ablation time (including total PVI ablation time, total LAA ablation time), total X-ray exposure time (the total time of X-ray imaging of the catheter).
Time frame: immediately after the procedure
Left atrial appendage closure rate 12 months after procedure
after occlusion device implantation, no forward or reverse blood flow through the occluder confirmed by ultrasound, residual forward or reverse blood flow at the edge of the occluder ≤3mm, peri-device leaks ≥grade 3)
Time frame: within 12 months after procedure
Incidence of ischemic stroke within 12 months after procedure (event/patient-year).
Ischemic stroke refers to the loss of neurological function caused by transient ischemic attack, cerebral thrombosis or cerebral embolism caused by the lesions of the brain itself and/or systemic blood circulation disorders leading to cerebral blood supply disorders. Ischemic stroke is defined as a modified Rankin score (mRS) ≥2 90 days after stroke onset.
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Time frame: within 12 months after procedure