Clinical trial NCT05114954: Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
Official title: A Prospective, Multicenter, Single-arm Objective Performance Criteria Evaluation of the Safety and Efficacy of a Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Hangzhou Dinova EP Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 75 years old;
2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation:

   At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
3. Ineffective or intolerant of at least one antiarrhythmic drug;
4. 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:

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
2. Persistent or long-standing persistent AF;
3. Previous surgery or catheter ablation for AF;
4. Participant known to require ablation outside the pulmonary vein or in cavotricuspid isthmus region (such as atrioventricular reentrant tachycardia, atrioventricular nodalreentry tachycardia, atrial tachycardia, atrial flutter, ventricular tachycardia and Wolff-Parkinson-White syndrome);
5. Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
6. Previous left atrial appendage closure;
7. Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 6-month interval preceding the consent date;
8. Any carotid artery stent implantation or endarterectomy within the previous 6 months;
9. Left atrial diameter≥50 mm (anteroposterior);
10. LVEF \<40% on admission, or NYHA class III and IV;
11. Presence of implanted ICD, CRT, permanent pacemaker, or any type of implantable device
12. Documented active thrombus in the left atrium or atrial appendage on imaging;
13. Rheumatic heart disease;
14. Uncontrollable high blood pressure;
15. Hypertrophic cardiomyopathy, myocardial thickening was significantly greater than or equal to 15mm;
16. Frequent premature ventricular beats;
17. Documented thromboembolic event (including TIA) within the past 6 months;
18. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access or catheter manipulation;
19. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
20. Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
21. Patients with acute systemic infection;
22. Serum creatinine is more than twice the upper normal limit, or have a history of kidney dialysis;
23. Women who are pregnant and/or breast feeding or unable to use contraception during the trial;
24. Enrollment in another clinical trial evaluating other devices or drugs during the same period;
25. Life expectancy less than 12 months (such as patients with advanced cancer);
26. Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.

Primary outcomes:
measure: 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.
timeFrame: 12 months after the ablation
Secondary outcomes:
measure: Acute isolation success rate
timeFrame: 20 minutes after the ablation
measure: Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
timeFrame: immediately after the ablation
measure: Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery
timeFrame: 3 months after the ablation
measure: Incidence of severe adverse events
timeFrame: 12 months after the ablation
measure: Incidence of device-related adverse events
timeFrame: 12 months after the ablation
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of the Northern Theater of the Chinese People's Liberation Army
Study officials:
References: