The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial fibrillation
This study is a premarket clinical trial of a pulsed field ablation catheter system, this study evaluates the safety and effectiveness of the pulsed field ablation catheter system developed and produced by Hangzhou Dinova EP Technology Co., Ltd. in the endovascular interventional treatment of patients with paroxysmal atrial fibrillation, and provided a clinical basis for the formal application of this product in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.
General Hospital of the Northern Theater of the Chinese People's Liberation Army
Shenyang, China
The effectiveness of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation is evaluated by the 12-month ablation success rate of atrial fibrillation.
12-month ablation success rate of atrial fibrillation is defined by ECG data (including ECG and 24-hour dynamic electrocardiogram (Holter)) during the effective evaluation period (blanking period to the end of 12-month follow-up), without recording AF, AFL or AT (Arrhythmia monitoring device ≥ 30 seconds).
Time frame: 12 months after the ablation
Acute isolation success rate
Acute isolation success refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
Time frame: 20 minutes after the ablation
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge 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), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter).
Time frame: immediately after the ablation
Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery
Including death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic circulatory embolism, pericarditis\*, cardiac tamponade/perforation, atrial esophageal fistula, and severe vascular access complications.
Time frame: 3 months after the ablation
Incidence of severe adverse events
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Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time frame: 12 months after the ablation
Incidence of device-related adverse events
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
Time frame: 12 months after the ablation