Paroxysmal Atrial FibrillationNCT05618340
3-Dimensional Mapping System: The PULSTAR Study
A study testing Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter in people with Paroxysmal Atrial Fibrillation, run by Shanghai Shangyang Medical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application. 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?
- Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2022to 1 Jun 2024
- 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
- ≥18 and ≤75 years of age.
- Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment.
- Clinical diagnosis of paroxysmal atrial fibrillation.
- Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.
- Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.
Who cannot join
- Patients who have undergone left atrial surgery
- Left atrial thrombosis
- Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment
- Anterior and posterior left atrial diameter ≥ 50 mm
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Previous atrial septal repair or atrial mucinous tumor
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- Active implants (e.g. pacemakers, ICDs, etc.) in the body
- NYHA class III-IV cardiac function [Appendix 1]
- Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
- Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
- Those with acute or severe systemic infections
- Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
- Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
- Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
- Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province
Shenyang, Liaoning, 110016
About this study
Official title: Pulsed Field Ablation Paroxysmal Atrial Fibrillation Using a Novel Spiral Catheter Integrated With a 3-Dimensional Mapping System: The PULSTAR Study
The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.
The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
- Keywords
- pulse field ablation, PFA, Paroxysmal Atrial Fibrillation, PAF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation CatheterDevice
Routinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance.
Pulmonary vein-by-pulmonary vein ablation using a circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation.
| Study group | Role | What they receive |
|---|---|---|
| Single group target value method | Experimental | This trial is a prospective, multicenter, single-group target value method study. All subjects are treated uniformly with the pulse ablation system provided in this protocol for paroxysmal AF, and the test results for the main indicators are statistically compared with the target values, a widely accepted standard in professional medicine, and the test results are considered to be attained if the one-sided 95% confidence interval for the test results is not lower than the target values. Receives: Device: Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Treatment Success at 3-Month Post-Procedure
Refers to the postoperative phase (blank) after 3 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Measured: Refers to the postoperative phase (blank) after 3 months postoperatively
Rate of Treatment Success at 6-Month Post-Procedure
Refers to the postoperative phase (blank) after 6 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Measured: Refers to the postoperative phase (blank) after 6 months postoperatively
Rate of Treatment Success at 12-Month Post-Procedure
Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Measured: Refers to the postoperative phase (blank) after 12 months postoperatively
Secondary outcomes (3)
Immediate success rate: pulmonary vein isolation after ablation
Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. Validation was a 20-minute wait after successful electrical isolation of the pulmonary vein, followed by reconfirmation of pulmonary vein block
Measured: 1 Day of surgery
Evaluation of Pulse Ablation Catheter
Evaluation of catheter operation performance;Catheter ablation parameters
Measured: 1 Day of surgery
Evaluation of Pulse Ablation equipment
System software operability;System operation stability;Hardware connection validity
Measured: 1 Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start26 Sep 2022
- Primary completion27 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This trial is a prospective, multicenter, single-group target value method study
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618340
- Sponsor's protocol ID
- DHF-SYPL-003(A)
- Status last verified
- Jul 2025
- First submitted
- 6 Nov 2022
- Last updated
- 24 Jul 2025
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation Paroxysmal Atrial Fibrillation Using a Novel Spiral Catheter Integrated With a 3-Dimensional Mapping System: The PULSTAR Study
- ClinicalTrials.gov ID
- NCT05618340
- Acronym / sponsor ID
- DHF-SYPL-003(A)
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- pulse field ablation, PFA, Paroxysmal Atrial Fibrillation, PAF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Nov 2022 (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 study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.
The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is a prospective, multicenter, single-group target value method study
| Arm | Type | Receives |
|---|---|---|
| Single group target value method | Experimental | Device: Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation CatheterThis trial is a prospective, multicenter, single-group target value method study. All subjects are treated uniformly with the pulse ablation system provided in this protocol for paroxysmal AF, and the test results for the main indicators are statistically compared with the target values, a widely accepted standard in professional medicine, and the test results are considered to be attained if the one-sided 95% confidence interval for the test results is not lower than the target values. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 and ≤75 years of age.
- Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting≥30s) within 1 year prior to enrollment.
- Clinical diagnosis of paroxysmal atrial fibrillation.
- Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.
- Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.
Key exclusion criteria (15 listed)
- Patients who have undergone left atrial surgery
- Left atrial thrombosis
- Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment
- Anterior and posterior left atrial diameter ≥ 50 mm
- Left ventricular ejection fraction (LVEF) ≤ 40%
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 |
|---|---|---|
| Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation CatheterRoutinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance. Pulmonary vein-by-pulmonary vein ablation using a circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation. | Device | Single group target value method |
Primary outcome
Rate of Treatment Success at 3-Month Post-Procedure
Time frame: Refers to the postoperative phase (blank) after 3 months postoperatively
Refers to the postoperative phase (blank) after 3 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Rate of Treatment Success at 6-Month Post-Procedure
Time frame: Refers to the postoperative phase (blank) after 6 months postoperatively
Refers to the postoperative phase (blank) after 6 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
Rate of Treatment Success at 12-Month Post-Procedure
Time frame: Refers to the postoperative phase (blank) after 12 months postoperatively
Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.
3 secondary outcomes
Immediate success rate: pulmonary vein isolation after ablation
Time frame: 1 Day of surgery
Evaluation of Pulse Ablation Catheter
Time frame: 1 Day of surgery
Evaluation of Pulse Ablation equipment
Time frame: 1 Day of surgery
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 24 Jul 2025.
- 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 Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter in people with Paroxysmal Atrial Fibrillation, run by Shanghai Shangyang Medical 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 15 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 24 Jul 2025. 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?
Rate of Treatment Success at 3-Month Post-Procedure (time frame: Refers to the postoperative phase (blank) after 3 months postoperatively). The study lists 3 primary outcomes in all. 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 24 Jul 2025.