Paroxysmal Atrial FibrillationNCT05114954
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
A study testing CardioPulsesTM pulsed field ablation system in people with Paroxysmal Atrial Fibrillation, run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- 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
- 158 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2021to 30 Mar 2023
- 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:
- At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
- Ineffective or intolerant of at least one antiarrhythmic drug;
- 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.
Who cannot join
- AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
- Persistent or long-standing persistent AF;
- Previous surgery or catheter ablation for AF;
- 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);
- Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
- Previous left atrial appendage closure;
Show all 26Show fewer
- Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 6-month interval preceding the consent date;
- Any carotid artery stent implantation or endarterectomy within the previous 6 months;
- Left atrial diameter≥50 mm (anteroposterior);
- LVEF <40% on admission, or NYHA class III and IV;
- Presence of implanted ICD, CRT, permanent pacemaker, or any type of implantable device
- Documented active thrombus in the left atrium or atrial appendage on imaging;
- Rheumatic heart disease;
- Uncontrollable high blood pressure;
- Hypertrophic cardiomyopathy, myocardial thickening was significantly greater than or equal to 15mm;
- Frequent premature ventricular beats;
- Documented thromboembolic event (including TIA) within the past 6 months;
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access or catheter manipulation;
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
- Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
- Patients with acute systemic infection;
- Serum creatinine is more than twice the upper normal limit, 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.
China1 site
General Hospital of the Northern Theater of the Chinese People's Liberation Army
Shenyang
About this study
Official title: A Prospective, Multicenter, Single-arm Objective Performance Criteria Evaluation of the Safety and Efficacy of a Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
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
Read the 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
- 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 |
|---|---|---|
| Experiment group | Experimental | Patients treated with PFA catheter. 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 (5)
Acute isolation success rate
Acute isolation success refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
Measured: 20 minutes after the ablation
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
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
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
Incidence of severe adverse events
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Measured: 12 months after the ablation
Incidence of device-related adverse events
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
Measured: 12 months 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 posted10 Nov 2021
- Study start27 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies 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
- 158 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
- NCT05114954
- Sponsor's protocol ID
- PFA001
- Status last verified
- Jun 2023
- First submitted
- 21 Oct 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38912887
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Objective Performance Criteria Evaluation of the Safety and Efficacy of a Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05114954
- Acronym / sponsor ID
- PFA001
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Hangzhou Dinova EP Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 10 Nov 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Device: CardioPulsesTM pulsed field ablation systemPatients treated with PFA catheter. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 75 years old;
- Patients diagnosed with symptomatic paroxysmal atrial fibrillation:
- At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
- Ineffective or intolerant of at least one antiarrhythmic drug;
- 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.
Key exclusion criteria (26 listed)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
- Persistent or long-standing persistent AF;
- Previous surgery or catheter ablation for AF;
- 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);
- Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
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 | Experiment group |
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).
5 secondary outcomes
Acute isolation success rate
Time frame: 20 minutes after the ablation
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
Time frame: immediately 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
Incidence of severe adverse events
Time frame: 12 months after the ablation
Incidence of device-related adverse events
Time frame: 12 months 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 7 Jun 2023.
- Derived from this study: PubMed 38912887Wang 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.
Related trials for Paroxysmal Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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Catheter Ablation Using a Novel Navigation and Imaging System
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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, 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 5 inclusion and 26 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 7 Jun 2023. 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?
On the ClinicalTrials.gov record for NCT05114954, which also lists 1 linked publication.
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 7 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.