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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation+E-SeaLATM | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-SeaLA, CardioPulse PFA system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical 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. | 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. | within 3 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Tang, professor | Contact | +86037158680341 | dinova_ep@dnaeps.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| 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) | 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. | within 12 months after procedure |
| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | China |
|
| General Hospital of Northern Theater Command | Recruiting | Shenyang | Liaoning | 110016 | China |
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