Atrial Fibrillation (AF)NCT07811934
Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation
A study testing Investigational Cardiac Pulsed Field Ablation (PFA) System and Conventional Radiofrequency (RF) Catheter Ablation System in people with Atrial Fibrillation (AF), run by Shanghai Shineyo Medical Co., Ltd..
Trial summary
The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac three-dimensional mapping system, works to treat symptomatic, recurrent, drug-refractory paroxysmal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Investigational Cardiac Pulsed Field Ablation (PFA) System and Conventional Radiofrequency (RF) Catheter Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years and ≤75 years, without gender restriction
- Patients with symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation
- Subjects scheduled for atrial fibrillation catheter ablation
- Subjects who agree to participate in this study and voluntarily sign the informed consent form
Who cannot join
- Persistent atrial fibrillation, or atrial fibrillation secondary to electrolyte disturbance, thyroid disease, alcohol or other reversible/non-cardiac causes
- Anterior-posterior left atrial diameter (measured by MRI, CT or TTE) ≥55 mm
- Prior history of any atrial surgery or atrial endocardial/epicardial ablation, except cavotricuspid isthmus ablation or right-sided supraventricular tachycardia ablation
- Existing left atrial thrombus, atrial myxoma, atrial septal patch or shunt device
- Prior or planned concomitant left atrial appendage closure procedure at index procedure
- Diagnosis of hypertrophic cardiomyopathy
Show all 22Show fewer
- History of congenital heart disease with residual anatomical or conduction abnormalities
- Hemodynamically significant valvular heart disease judged by investigator to be ineligible for enrollment
- Prior valve repair or valve replacement surgery
- Implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device
- NYHA functional class Ⅲ-Ⅳ
- Left ventricular ejection fraction (LVEF) ≤40%
- Symptomatic hypotension or uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg in two baseline measurements)
- Symptomatic resting bradycardia or type-second-degree or third-degree atrioventricular block
- Contraindication to systemic anticoagulation, or unwillingness to receive systemic anticoagulation
- Medical conditions that may interfere with study participation, assessment or treatment, significantly increase study-related risk, or alter study outcomes, including but not limited to: moderate-to-severe COPD, moderate-to-severe pulmonary hypertension, or diseases causing severe dyspnea or resting hypoxemia; renal insufficiency (eGFR<30 ml/min/1.73 m²) or history of hemodialysis or renal transplantation; active malignancy or treated malignancy within 24 months prior to enrollment (excluding basal cell or squamous cell skin carcinoma); active systemic infection
- Myocardial infarction, unstable angina, heart failure hospitalization within 3 months prior to enrollment; any cardiac interventional or open-heart surgery within 1 month prior to enrollment (coronary angiography excluded)
- Stroke (excluding silent stroke), transient ischemic attack or any thromboembolic event within 3 months prior to enrollment
- Expected survival less than 1 year
- Female subjects who are pregnant, lactating, or planning pregnancy during study period
- Participation in another interventional device clinical trial within 1 month before enrollment, or within 5 half-lives of last study drug for drug clinical trials
- Any other condition judged by investigator to make the subject unsuitable for this clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of Cardiac Pulsed Field Ablation Devices Combined With Single-use Spherical Pulsed Ablation Catheters in Treating Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac three-dimensional mapping system, works to treat symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation. It will also learn about the safety of this set of investigational medical devices. The main questions it aims to answer are:
Does the combination of the cardiac pulsed field ablation device and the single-use spherical pulsed ablation catheter improve the 12-month post-procedure treatment success rate for participants with paroxysmal atrial fibrillation? What adverse events and medical problems do participants experience after receiving the investigational pulsed field ablation treatment? Researchers will compare the investigational pulsed field ablation therapy to the clinically recognized radiofrequency ablation therapy using the marketed Diagnostic/Ablation Deflectable Tip Catheter to verify the non-inferior effectiveness and safety of the test devices for treating paroxysmal atrial fibrillation.
Read more
Participants will:
Undergo screening assessments within 14 days before the procedure, including signing informed consent, completing medical history collection, physical vital sign checks, laboratory tests, 12-lead ECG, echocardiogram, baseline quality of life score evaluation, and confirmation of meeting all inclusion criteria without any exclusion criteria Be randomly assigned to either the investigational pulsed field ablation group or the control radiofrequency ablation group on the day of surgery Receive the assigned ablation procedure, with intra-operative recordings of core surgical parameters, pain score assessment, and investigational device performance evaluation Complete post-procedure assessments before discharge (within 7 days after surgery), including post-operative laboratory tests, pain follow-up, and recording of re-ablation, electrical cardioversion, readmission events, adverse events and concomitant medications Return for follow-up visits or complete telephone follow-ups at 1 month (±7 days), 3 months (±15 days), 6 months (±30 days) and 12 months (±30 days) after the procedure, which include physical vital sign checks, remote ECG monitoring (daily for the first 3 months after surgery, weekly from month 4 to month 12, and as needed when symptoms occur), 72-hour Holter and 12-lead ECG tests at the 6-month and 12-month visits, echocardiogram reexamination, repeated quality of life scoring, and continuous recording of arrhythmia recurrence, subsequent treatment events, adverse events and medication status Keep a symptom and ECG monitoring diary for the entire 12-month follow-up period after the procedure, as required by the trial protocol
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Investigational Cardiac Pulsed Field Ablation (PFA) System, Conventional Radiofrequency (RF) Catheter 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.
Investigational Cardiac Pulsed Field Ablation (PFA) SystemDevice
It consists of a cardiac pulsed electric field ablation apparatus and a single-use spherical pulsed ablation catheter, which can be paired with an optional cardiac three-dimensional mapping system to complete pulsed electric field ablation in the pulmonary vein antrum region, achieve pulmonary vein electrical isolation, and is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation.
Conventional Radiofrequency (RF) Catheter Ablation SystemDevice
Using the commercially available diagnostic/ablation steerable-tip catheter in combination with a conventional clinical radiofrequency ablation device, point-by-point radiofrequency ablation is performed on the pulmonary vein antrum to achieve pulmonary vein electrical isolation. This is the current standard clinical treatment for paroxysmal atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Cardiac Pulsed Field Ablation (PFA) Arm | Experimental | Intervention group receiving cardiac pulsed field ablation for paroxysmal atrial fibrillation Receives: Device: Investigational Cardiac Pulsed Field Ablation (PFA) System |
| Control Radiofrequency (RF) Catheter Ablation Arm | Active comparator | Control group receiving conventional radiofrequency catheter ablation for paroxysmal atrial fibrillation Receives: Device: Conventional Radiofrequency (RF) Catheter Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with freedom from atrial fibrillation at 12 months post-index ablation (90-day post-procedure blanking period)
Treatment success at 12 months post-index ablation is defined as no amiodarone use and no repeat ablation during the 3-month post-procedure blanking period, except repeat ablation for CTI-dependent atrial flutter. Following the end of the blanking period (i.e., 3 months to 12 months after the procedure), subjects shall have no use of Class I/III antiarrhythmic drugs, no repeat ablation, no electrical cardioversion (interventions for CTI-dependent atrial flutter excluded), and no episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds confirmed by electrocardiogram or Holter monitoring (CTI-dependent atrial flutter excluded).
Measured: 12 months post-index ablation
Secondary outcomes (27)
Proportion of participants with treatment success at 12 months post-index ablation
Measured: From the end of 30-day post-procedure blanking period to 12 months after the index ablation
Acute procedural success rate on the day of index ablation
Measured: On the day of index ablation (intra-procedure completion)
Atrial fibrillation burden assessed by 72-hour Holter monitoring
Measured: 6-month and 12-month follow-up; daily monitoring 1-3 months post-procedure, weekly monitoring 4-12 months post-procedure, additionally upon symptom occurrence
Pain score at 2-hours and 24-hours after index ablation
Measured: 2 hours after recovery from anesthesia; 24 hours post-index ablation
Recurrence rate of early atrial tachyarrhythmias (atrial fibrillation / atrial flutter / atrial tachycardia)
Measured: 1-month and 3-month post-index ablation
Proportion of participants receiving electrical cardioversion, repeat ablation, emergency department visit or hospitalization due to documented recurrent atrial arrhythmia
Measured: Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation
Proportion of participants with re-initiation of antiarrhythmic drugs
Measured: 1-month, 3-month, 6-month, 12-month post-index ablation
Time from index ablation to first documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia
Measured: Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits
Symptom-free survival of participants
Measured: 1-month, 3-month, 6-month, 12-month post-index ablation
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) total score from baseline
The change from baseline in the total score of the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire. Measurement tool: AFEQT questionnaire. Unit: score.
Measured: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
Performance evaluation of investigational device
Measured: On the day of index ablation
Incidence of major adverse events
Measured: Within 7 days post-index ablation and up to 12 months post-index ablation
Incidence of device- or procedure-related stroke or transient ischemic attack (TIA)
Number of subjects experiencing device- or procedure-related stroke or transient ischemic attack (TIA). Unit: percentage of subjects.
Measured: Through study completion, average of 12-month follow-up
Incidence of device- related serious adverse events (SAE)
Number of device-related serious adverse events divided by the total number of serious adverse events that occurred during follow-up. Measurement tool: clinical adverse-event reporting. Unit: percentage of SAE events.
Measured: Through study completion, average of 12-month follow-up
Laboratory values of myocardial injury biomarkers
Laboratory values of myocardial injury biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: laboratory value.
Measured: Within 48-hours post-index ablation
Incidence of hemolysis-associated renal injury
Number of subjects with hemolysis-associated renal injury occurring within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: percentage of subjects.
Measured: Within 48-hours post-index ablation
Incidence of other adverse events (AE)
Number of subjects experiencing other adverse events (AEs) throughout the study period. Unit: percentage of subjects.
Measured: Through study completion, average of 12-month follow-up
Total index ablation procedure duration
Total time duration of the index ablation procedure. Unit: minutes.
Measured: Periprocedural
Left-atrial device dwell time during index ablation
Total dwell time of investigational device within left atrium during index ablation. Unit: minutes.
Measured: Periprocedural
Pulmonary vein isolation (PVI) procedural time
Time spent for pulmonary vein isolation (PVI) manipulation during index ablation. Unit: minutes.
Measured: Intra-procedural
Total fluoroscopy time during index ablation
Total fluoroscopy exposure time during index ablation. Unit: minutes.
Measured: Intra-procedural
Total contrast media volume administered
Total volume of contrast media used during index ablation. Unit: mL.
Measured: Intra-procedural
Number of ablation energy deliveries
Total count of ablation energy deliveries applied during index ablation. Unit: number of subjects (count).
Measured: Intra-procedural
Incidence of other serious adverse events (SAE) throughout the study period
Number of subjects with other serious adverse events occurring during the entire study period. Measurement tool: serious adverse-event reporting. Unit: percentage of subjects.
Measured: Through study completion, average of 12-month follow-up
Laboratory values of inflammatory biomarkers
Laboratory values of inflammatory biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: laboratory value.
Measured: Within 48-hours post-index ablation
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility score from baseline
The change from baseline in the utility index score calculated from the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Measurement tool: EQ-5D-5L questionnaire. Unit: index score.
Measured: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
Proportion of procedure-related serious adverse events (SAEs) among all SAEs
Number of procedure-related serious adverse events divided by the total number of serious adverse events that occurred during follow-up. Measurement tool: clinical adverse-event reporting. Unit: percentage of SAE events.
Measured: Through study completion, average of 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Shineyo Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811934
- Sponsor's protocol ID
- (2026)-(289)
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-participant-level data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of Cardiac Pulsed Field Ablation Devices Combined With Single-use Spherical Pulsed Ablation Catheters in Treating Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07811934
- Acronym / sponsor ID
- (2026)-(289)
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Shanghai Shineyo Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Sep 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.
The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac three-dimensional mapping system, works to treat symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation. It will also learn about the safety of this set of investigational medical devices. The main questions it aims to answer are:
Does the combination of the cardiac pulsed field ablation device and the single-use spherical pulsed ablation catheter improve the 12-month post-procedure treatment success rate for participants with paroxysmal atrial fibrillation? What adverse events and medical problems do participants experience after receiving the investigational pulsed field ablation treatment? Researchers will compare the investigational pulsed field ablation therapy to the clinically recognized radiofrequency ablation therapy using the marketed Diagnostic/Ablation Deflectable Tip Catheter to verify the non-inferior effectiveness and safety of the test devices for treating paroxysmal atrial fibrillation.
Participants will:
Undergo screening assessments within 14 days before the procedure, including signing informed consent, completing medical history collection, physical vital sign checks, laboratory tests, 12-lead ECG, echocardiogram, baseline quality of life score evaluation, and confirmation of meeting all inclusion criteria without any exclusion criteria Be randomly assigned to either the investigational pulsed field ablation group or the control radiofrequency ablation group on the day of surgery Receive the assigned ablation procedure, with intra-operative recordings of core surgical parameters, pain score assessment, and investigational device performance evaluation Complete post-procedure assessments before discharge (within 7 days after surgery), including post-operative laboratory tests, pain follow-up, and recording of re-ablation, electrical cardioversion, readmission events, adverse events and concomitant medications Return for follow-up visits or complete telephone follow-ups at 1 month (±7 days), 3 months (±15 days), 6 months (±30 days) and 12 months (±30 days) after the procedure, which include physical vital sign checks, remote ECG monitoring (daily for the first 3 months after surgery, weekly from month 4 to month 12, and as needed when symptoms occur), 72-hour Holter and 12-lead ECG tests at the 6-month and 12-month visits, echocardiogram reexamination, repeated quality of life scoring, and continuous recording of arrhythmia recurrence, subsequent treatment events, adverse events and medication status Keep a symptom and ECG monitoring diary for the entire 12-month follow-up period after the procedure, as required by the trial protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Cardiac Pulsed Field Ablation (PFA) Arm | Experimental | Device: Investigational Cardiac Pulsed Field Ablation (PFA) SystemIntervention group receiving cardiac pulsed field ablation for paroxysmal atrial fibrillation |
| Control Radiofrequency (RF) Catheter Ablation Arm | Active comparator | Device: Conventional Radiofrequency (RF) Catheter Ablation SystemControl group receiving conventional radiofrequency catheter ablation for paroxysmal atrial fibrillation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years and ≤75 years, without gender restriction
- Patients with symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation
- Subjects scheduled for atrial fibrillation catheter ablation
- Subjects who agree to participate in this study and voluntarily sign the informed consent form
Key exclusion criteria (22 listed)
- Persistent atrial fibrillation, or atrial fibrillation secondary to electrolyte disturbance, thyroid disease, alcohol or other reversible/non-cardiac causes
- Anterior-posterior left atrial diameter (measured by MRI, CT or TTE) ≥55 mm
- Prior history of any atrial surgery or atrial endocardial/epicardial ablation, except cavotricuspid isthmus ablation or right-sided supraventricular tachycardia ablation
- Existing left atrial thrombus, atrial myxoma, atrial septal patch or shunt device
- Prior or planned concomitant left atrial appendage closure procedure at index procedure
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 |
|---|---|---|
| Investigational Cardiac Pulsed Field Ablation (PFA) SystemIt consists of a cardiac pulsed electric field ablation apparatus and a single-use spherical pulsed ablation catheter, which can be paired with an optional cardiac three-dimensional mapping system to complete pulsed electric field ablation in the pulmonary vein antrum region, achieve pulmonary vein electrical isolation, and is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation. | Device | Investigational Cardiac Pulsed Field Ablation (PFA) Arm |
| Conventional Radiofrequency (RF) Catheter Ablation SystemUsing the commercially available diagnostic/ablation steerable-tip catheter in combination with a conventional clinical radiofrequency ablation device, point-by-point radiofrequency ablation is performed on the pulmonary vein antrum to achieve pulmonary vein electrical isolation. This is the current standard clinical treatment for paroxysmal atrial fibrillation. | Device | Control Radiofrequency (RF) Catheter Ablation Arm |
Primary outcome
Proportion of participants with freedom from atrial fibrillation at 12 months post-index ablation (90-day post-procedure blanking period)
Time frame: 12 months post-index ablation
Treatment success at 12 months post-index ablation is defined as no amiodarone use and no repeat ablation during the 3-month post-procedure blanking period, except repeat ablation for CTI-dependent atrial flutter. Following the end of the blanking period (i.e., 3 months to 12 months after the procedure), subjects shall have no use of Class I/III antiarrhythmic drugs, no repeat ablation, no electrical cardioversion (interventions for CTI-dependent atrial flutter excluded), and no episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds confirmed by electrocardiogram or Holter monitoring (CTI-dependent atrial flutter excluded).
27 secondary outcomes
Proportion of participants with treatment success at 12 months post-index ablation
Time frame: From the end of 30-day post-procedure blanking period to 12 months after the index ablation
Acute procedural success rate on the day of index ablation
Time frame: On the day of index ablation (intra-procedure completion)
Atrial fibrillation burden assessed by 72-hour Holter monitoring
Time frame: 6-month and 12-month follow-up; daily monitoring 1-3 months post-procedure, weekly monitoring 4-12 months post-procedure, additionally upon symptom occurrence
Pain score at 2-hours and 24-hours after index ablation
Time frame: 2 hours after recovery from anesthesia; 24 hours post-index ablation
Recurrence rate of early atrial tachyarrhythmias (atrial fibrillation / atrial flutter / atrial tachycardia)
Time frame: 1-month and 3-month post-index ablation
Proportion of participants receiving electrical cardioversion, repeat ablation, emergency department visit or hospitalization due to documented recurrent atrial arrhythmia
Time frame: Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation
Proportion of participants with re-initiation of antiarrhythmic drugs
Time frame: 1-month, 3-month, 6-month, 12-month post-index ablation
Time from index ablation to first documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia
Time frame: Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits
Symptom-free survival of participants
Time frame: 1-month, 3-month, 6-month, 12-month post-index ablation
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) total score from baseline
Time frame: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
Performance evaluation of investigational device
Time frame: On the day of index ablation
Incidence of major adverse events
Time frame: Within 7 days post-index ablation and up to 12 months post-index ablation
Incidence of device- or procedure-related stroke or transient ischemic attack (TIA)
Time frame: Through study completion, average of 12-month follow-up
Incidence of device- related serious adverse events (SAE)
Time frame: Through study completion, average of 12-month follow-up
Laboratory values of myocardial injury biomarkers
Time frame: Within 48-hours post-index ablation
Incidence of hemolysis-associated renal injury
Time frame: Within 48-hours post-index ablation
Incidence of other adverse events (AE)
Time frame: Through study completion, average of 12-month follow-up
Total index ablation procedure duration
Time frame: Periprocedural
Left-atrial device dwell time during index ablation
Time frame: Periprocedural
Pulmonary vein isolation (PVI) procedural time
Time frame: Intra-procedural
Total fluoroscopy time during index ablation
Time frame: Intra-procedural
Total contrast media volume administered
Time frame: Intra-procedural
Number of ablation energy deliveries
Time frame: Intra-procedural
Incidence of other serious adverse events (SAE) throughout the study period
Time frame: Through study completion, average of 12-month follow-up
Laboratory values of inflammatory biomarkers
Time frame: Within 48-hours post-index ablation
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility score from baseline
Time frame: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
Proportion of procedure-related serious adverse events (SAEs) among all SAEs
Time frame: Through study completion, average of 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual-participant-level data will not be shared with other researchers.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Cardiac Pulsed Field Ablation (PFA) System and Conventional Radiofrequency (RF) Catheter Ablation System in people with Atrial Fibrillation (AF), run by Shanghai Shineyo Medical Co., Ltd..
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 22 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Pan (86-18621903981, panshuang@shineyomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with freedom from atrial fibrillation at 12 months post-index ablation (90-day post-procedure blanking period) (time frame: 12 months post-index 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 10 Sep 2026.