Atrial Fibrillation FlutteringNCT07410962
Safety and Initial Efficacy Study of a Cardiac Surgical Pulsed Field Ablation System for the Treatment of Atrial Fibrillation
A study testing Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode in people with Atrial Fibrillation Fluttering, run by SuZhou Sinus Medical Technologies Co.,Ltd.
Trial summary
This study is a prospective, single-center, single-arm, non-randomized study focused on safety and preliminary efficacy, aiming to evaluate the safety and preliminary efficacy of a cardiac pulsed field ablation device and a single-use cardiac surgical pulsed field ablation electrode for elective cardiovascular surgery… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation Fluttering
- What is being tested?
- Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2026to 30 Jan 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥ 18 years and ≤ 80 years;
- Subjects are willing and able to sign the informed consent form to receive study treatment, including surgical atrial fibrillation ablation, and complete the follow-up specified in the clinical study protocol;
- Subjects with a history, electrocardiogram, or Holter ECG confirming paroxysmal atrial fibrillation, persistent atrial fibrillation (lasting more than seven days, or less than seven days but requiring drug or electrical cardioversion), or long-standing persistent atrial fibrillation (lasting more than one year);
- Left ventricular ejection fraction > 30% (determined by echocardiography or cardiac catheterization within 60 days prior to enrollment, as recorded in the patient's medical history);
- Subjects scheduled to undergo open-heart surgery, including one or more of the following cardiac surgeries performed under direct vision: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, and coronary artery bypass grafting;
- Subjects with an expected survival of ≥ 1 year.
Who cannot join
- Subjects with implanted electronic medical devices (such as pacemakers, ICDs, or CRT) or left atrial appendage devices;
- Subjects with artificial heart valves;
- Subjects with atrial fibrillation only, without indications for coronary artery bypass grafting (CABG) and/or valve surgery;
- History of previous atrial fibrillation ablation, atrioventricular (AV) node ablation, or Maze procedure;
- History of previous cardiac surgery (reoperation);
- Wolff-Parkinson-White (WPW) syndrome or other supraventricular arrhythmias, AV nodal reentry, ventricular arrhythmias requiring antiarrhythmic drug treatment, or uncontrolled bradyarrhythmias (sinus bradycardia, junctional rhythm, ventricular escape rhythm, sinus arrest, sinoatrial block, second-degree AV block, third-degree AV block, and sick sinus syndrome).
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
This study is a prospective, single-center, single-arm, non-randomized study focused on safety and preliminary efficacy, aiming to evaluate the safety and preliminary efficacy of a cardiac pulsed field ablation device and a single-use cardiac surgical pulsed field ablation electrode for elective cardiovascular surgery combined with Cox-maze IV surgery as a reference treatment for atrial fibrillation. Adult subjects meeting the clinical indications for concomitant cardiac surgery will undergo the Cox-maze IV procedure as a reference, which includes isolation of the left and right pulmonary veins and a series of ablation lines to create a box isolation area on the posterior free wall of the left atrium, as well as linear ablation on the mitral annulus and left atrial appendage. On the right side of the heart, ablation will be performed on the anterior free wall of the right atrium, right atrial appendage, and from the right atrial appendage to the tricuspid annulus, with immediate verification of effective pulmonary vein isolation. After the completion of surgical ablation, all subjects will be followed up in the hospital before discharge, and at 30±7 days, 90±14 days, and 180±30 days postoperatively. The blanking period refers to a specified 90-day observation period after surgery during which events are not included in the secondary efficacy evaluation. All subjects will undergo assessment based on electrocardiographic records at 180 days following surgical ablation to evaluate the success of the procedure.
- Conditions
- Atrial Fibrillation Fluttering
- Being tested
- Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrodeDevice
Subjects will undergo ablation with reference to the Cox-maze IV surgical approach, using a cardiac pulsed field ablation device and a disposable cardiac surgical pulsed field ablation electrode. The study period is expected to be 195 days, with a screening period of up to 14 days, a treatment period of 1 day, and a follow-up period of 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode | Experimental | Not described Receives: Device: Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The incidence of acute major adverse events (MAE) occurring within 30 days after ablation
Including death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or serious bleeding (bleeding requiring transfusion of more than 2 units of blood and surgical intervention).
Measured: 30 days after ablation
Efficacy: The rate of freedom from atrial fibrillation events at 180 days post-ablation without the use of antiarrhythmic drugs (AADs)
defined as no recorded atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) during the efficacy evaluation period.
Measured: 180 days after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start6 Feb 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation FlutteringStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410962
- Sponsor's protocol ID
- B2025-844R
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Initial Efficacy Study of a Cardiac Surgical Pulsed Field Ablation System for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07410962
- Acronym / sponsor ID
- B2025-844R
- Conditions
- Atrial Fibrillation Fluttering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 6 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 Feb 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 study is a prospective, single-center, single-arm, non-randomized study focused on safety and preliminary efficacy, aiming to evaluate the safety and preliminary efficacy of a cardiac pulsed field ablation device and a single-use cardiac surgical pulsed field ablation electrode for elective cardiovascular surgery combined with Cox-maze IV surgery as a reference treatment for atrial fibrillation. Adult subjects meeting the clinical indications for concomitant cardiac surgery will undergo the Cox-maze IV procedure as a reference, which includes isolation of the left and right pulmonary veins and a series of ablation lines to create a box isolation area on the posterior free wall of the left atrium, as well as linear ablation on the mitral annulus and left atrial appendage. On the right side of the heart, ablation will be performed on the anterior free wall of the right atrium, right atrial appendage, and from the right atrial appendage to the tricuspid annulus, with immediate verification of effective pulmonary vein isolation. After the completion of surgical ablation, all subjects will be followed up in the hospital before discharge, and at 30±7 days, 90±14 days, and 180±30 days postoperatively. The blanking period refers to a specified 90-day observation period after surgery during which events are not included in the secondary efficacy evaluation. All subjects will undergo assessment based on electrocardiographic records at 180 days following surgical ablation to evaluate the success of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode | Experimental | Device: Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged ≥ 18 years and ≤ 80 years;
- Subjects are willing and able to sign the informed consent form to receive study treatment, including surgical atrial fibrillation ablation, and complete the follow-up specified in the clinical study protocol;
- Subjects with a history, electrocardiogram, or Holter ECG confirming paroxysmal atrial fibrillation, persistent atrial fibrillation (lasting more than seven days, or less than seven days but requiring drug or electrical cardioversion), or long-standing persistent atrial fibrillation (lasting more than one year);
- Left ventricular ejection fraction > 30% (determined by echocardiography or cardiac catheterization within 60 days prior to enrollment, as recorded in the patient's medical history);
- Subjects scheduled to undergo open-heart surgery, including one or more of the following cardiac surgeries performed under direct vision: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, and coronary artery bypass grafting;
Key exclusion criteria (6 listed)
- Subjects with implanted electronic medical devices (such as pacemakers, ICDs, or CRT) or left atrial appendage devices;
- Subjects with artificial heart valves;
- Subjects with atrial fibrillation only, without indications for coronary artery bypass grafting (CABG) and/or valve surgery;
- History of previous atrial fibrillation ablation, atrioventricular (AV) node ablation, or Maze procedure;
- History of previous cardiac surgery (reoperation);
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 |
|---|---|---|
| Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrodeSubjects will undergo ablation with reference to the Cox-maze IV surgical approach, using a cardiac pulsed field ablation device and a disposable cardiac surgical pulsed field ablation electrode. The study period is expected to be 195 days, with a screening period of up to 14 days, a treatment period of 1 day, and a follow-up period of 180 days. | Device | Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode |
Primary outcome
Safety: The incidence of acute major adverse events (MAE) occurring within 30 days after ablation
Time frame: 30 days after ablation
Including death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or serious bleeding (bleeding requiring transfusion of more than 2 units of blood and surgical intervention).
Efficacy: The rate of freedom from atrial fibrillation events at 180 days post-ablation without the use of antiarrhythmic drugs (AADs)
Time frame: 180 days after ablation
defined as no recorded atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) during the efficacy evaluation period.
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 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation Fluttering
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
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 Cardiac pulse field ablation device and disposable cardiac surgical pulse field ablation electrode in people with Atrial Fibrillation Fluttering, run by SuZhou Sinus Medical Technologies 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 6 inclusion and 6 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 13 Feb 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 zhangxue (86+13122163513, zhangxue@sinusmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: The incidence of acute major adverse events (MAE) occurring within 30 days after ablation (time frame: 30 days after ablation). The study lists 2 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 13 Feb 2026.