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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation (PAF)
• Intervention / Treatment: Device: CardioPulsesTM pulsed field ablation system

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Fuwai Yunnan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device: CardioPulse PFA system; Pulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd).	Device: CardioPulsesTM pulsed field ablation system; Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Acute isolation success rate	30 minutes after CPVI, inflow block was confirmed in all clinically relevant pulmonary veins following induction with isoproterenol.	30 minutes after the ablation
The rate of repeat ablation within 12 months.	The rate of repeat ablation within 12 months.	12 months after the ablation
Procedure efficiency	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

Collaborators and Investigators

• Sponsor: Hangzhou Dinova EP Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): April 10, 2022

Study Registration Dates

• First Submitted: February 28, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PFA001-FIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No