Paroxysmal Atrial Fibrillation (PAF)
Conditions
Brief summary
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.
Interventions
Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.
Sponsors
Hangzhou Dinova EP Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 months after the ablation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute isolation success rate | 30 minutes after the ablation | 30 minutes after CPVI, inflow block was confirmed in all clinically relevant pulmonary veins following induction with isoproterenol. |
| The rate of repeat ablation within 12 months. | 12 months after the ablation | The rate of repeat ablation within 12 months. |
| Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery | 3 months after the ablation | 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. |
| Procedure efficiency | immediately after the ablation | 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). |
Countries
China
Outcome results
None listed