Paroxysmal Atrial Fibrillation (PAF)NCT07452211
First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient
A study testing CardioPulsesTM pulsed field ablation system in people with Paroxysmal Atrial Fibrillation (PAF), run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- CardioPulsesTM pulsed field ablation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2020to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- CardioPulsesTM pulsed field ablation system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioPulsesTM pulsed field ablation systemDevice
Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: CardioPulsesTM pulsed field ablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after the ablation
Secondary outcomes (4)
Acute isolation success rate
30 minutes after CPVI, inflow block was confirmed in all clinically relevant pulmonary veins following induction with isoproterenol.
Measured: 30 minutes after the ablation
The rate of repeat ablation within 12 months.
The rate of repeat ablation within 12 months.
Measured: 12 months after the ablation
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.
Measured: 3 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).
Measured: immediately after the ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start18 Dec 2020
- Primary completion10 Apr 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Dinova EP Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452211
- Sponsor's protocol ID
- PFA001-FIM
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Man Study of Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 1 Patient
- ClinicalTrials.gov ID
- NCT07452211
- Acronym / sponsor ID
- PFA001-FIM
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hangzhou Dinova EP Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: CardioPulse PFA system | Experimental | Device: CardioPulsesTM pulsed field ablation systemPulmonary vein isolation(PVI) was performed with the novel hex spline PFA ablation catheter( CardioPulseTM PFA system, Hangzhou Dinova EP Technology Co., Ltd). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioPulsesTM pulsed field ablation systemUsing pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation. | Device | Device: CardioPulse PFA system |
Primary outcome
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).
4 secondary outcomes
Acute isolation success rate
Time frame: 30 minutes after the ablation
The rate of repeat ablation within 12 months.
Time frame: 12 months after the ablation
Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery
Time frame: 3 months after the ablation
Procedure efficiency
Time frame: immediately after the ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioPulsesTM pulsed field ablation system in people with Paroxysmal Atrial Fibrillation (PAF), run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months after the ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.