NCT07452211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 28, 2026

Last Update Submit

February 28, 2026

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Acute isolation success rate

    30 minutes after the ablation

  • The rate of repeat ablation within 12 months.

    12 months after the ablation

  • Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery

    3 months after the ablation

  • Procedure efficiency

    immediately after the ablation

Study Arms (1)

Device: CardioPulse PFA system

EXPERIMENTAL

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

Interventions

CardioPulsesTM pulsed field ablation systemDEVICE

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

Device: CardioPulse PFA system

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 75 years old;
  • 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.
  • Capable and willing to comply with all preoperative and postoperative follow-up examinations and requirements.
  • Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself.

You may not qualify if:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
  • AF episodes lasting more than 7 days;
  • History of previous AF ablation therapy;
  • Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
  • Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 3-month interval preceding the consent date;
  • Hypertrophic Obstructive Cardiomyopathy (HOCM);
  • NYHA class III and IV;
  • Presence of implanted ICD, CRT;
  • Documented active thrombus in the left atrium or atrial appendage on imaging;
  • Any carotid artery stent implantation or endarterectomy within the previous 6 months;
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
  • Known pulmonary vein stenosis
  • Contraindication to isoproterenol therapy.
  • Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
  • Patients with acute systemic infection;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Yunnan Hospital

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2026

First Posted

March 5, 2026

Study Start

December 18, 2020

Primary Completion

April 10, 2022

Study Completion

April 10, 2022

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)