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NCT Number: NCT07452211

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Yunnan Hospital

Kunming, Yunnan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • (eGFR)< 60mL/min/1.73m2, or have a history of kidney dialysis;
  • Women who are pregnant and/or breast feeding or unable to use contraception during the trial;
  • Enrollment in another clinical trial evaluating other devices or drugs during the same period;
  • Life expectancy less than 12 months (such as patients with advanced cancer);
  • Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.

Treatment and study plan

CardioPulsesTM pulsed field ablation system

Device

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

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.

    Time frame: 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 outcomes

  1. Acute isolation success rate

    Time frame: 30 minutes after the ablation

    30 minutes after CPVI, inflow block was confirmed in all clinically relevant pulmonary veins following induction with isoproterenol.

  2. The rate of repeat ablation within 12 months.

    Time frame: 12 months after the ablation

    The rate of repeat ablation within 12 months.

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

    Time frame: 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.

  4. Procedure efficiency

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hangzhou Dinova EP Technology Co., Ltd

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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