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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment group | Experimental | Patients treated with PFA catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioPulsesTM pulsed field ablation system | Device | Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months after the ablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes after the ablation |
| Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time |
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Inclusion Criteria:
Patients aged 18 to 75 years old;
Patients diagnosed with symptomatic paroxysmal atrial fibrillation:
At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
Ineffective or intolerant of at least one antiarrhythmic drug;
Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of the Northern Theater of the Chinese People's Liberation Army | Shenyang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38912887 | Derived | Wang Z, Tang M, Reddy VY, Chu H, Liu X, Xue Y, Wang J, Xu J, Liu S, Xu W, Zhang Z, Han B, Hong L, Yang B, Ding M, Liang M. Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study. Europace. 2024 Jul 2;26(7):euae174. doi: 10.1093/europace/euae174. |
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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). |
| 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. | 3 months after the ablation |
| Incidence of severe adverse events | 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. | 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. | 12 months after the ablation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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