Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)

NCT ID: NCT05114954

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2023-03-30

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experiment group

Patients treated with PFA catheter.

Group Type: EXPERIMENTAL

CardioPulsesTM pulsed field ablation system

Intervention Type: DEVICE

Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.

Interventions

CardioPulsesTM pulsed field ablation system

Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Dinova EP Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hospital of the Northern Theater of the Chinese People's Liberation Army

Shenyang, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38912887 (View on PubMed)

Other Identifiers

PFA001

Identifier Type: -

Identifier Source: org_study_id