First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient

First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient

This is the first in man study of CadioPulseTM ( pulsed field ablation system) developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can be used for Pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation. This study aims to initially verify the safety and efficacy of the device.

Inclusion Criteria:

1. Patients aged 18 to 75 years old;
2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation: (The medical records documented recurrent and self-terminating atrial fibrillation).Electrocardiographic recordings may include, but are not limited to, electrocardiography (ECG), ambulatory ECG monitoring, or telemetric ECG.
3. Capable and willing to comply with all preoperative and postoperative follow-up examinations and requirements.
4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself.

Exclusion Criteria:

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
2. AF episodes lasting more than 7 days;
3. History of previous AF ablation therapy;
4. Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
5. Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 3-month interval preceding the consent date;
6. Hypertrophic Obstructive Cardiomyopathy (HOCM);
7. NYHA class III and IV;
8. Presence of implanted ICD, CRT;
9. Documented active thrombus in the left atrium or atrial appendage on imaging;
10. Any carotid artery stent implantation or endarterectomy within the previous 6 months;
11. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
12. Known pulmonary vein stenosis
13. Contraindication to isoproterenol therapy.
14. Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
15. Patients with acute systemic infection;
16. （eGFR）< 60mL/min/1.73m2, or have a history of kidney dialysis;
17. Women who are pregnant and/or breast feeding or unable to use contraception during the trial;
18. Enrollment in another clinical trial evaluating other devices or drugs during the same period;
19. Life expectancy less than 12 months (such as patients with advanced cancer);
20. Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.