Paroxysmal Atrial Fibrillation (PAF)NCT07762742
A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
A study testing Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. and Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. in people with Paroxysmal Atrial Fibrillation (PAF), run by China National Center for Cardiovascular Diseases.
Trial summary
This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). 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?
- Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. and Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 28 Feb 2029
- 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
- Adult patients aged 18 to 75 years (including 18 years and 75 years of age).
- Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation.
- Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Who cannot join
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes;
- Previous history of catheter ablation or cardiac surgery for atrial fibrillation;
- Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair;
- Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials;
- Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.);
- Persistent atrial fibrillation;
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- Left atrial anteroposterior diameter (LAD) > 55 mm on transthoracic echocardiography;
- Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial;
- Current participation in another pharmaceutical or medical device clinical study.
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 prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation., Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.Procedure or surgery
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.Procedure or surgery
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous pulsed field ablation performed under ultrasound-only guidance. | Experimental | Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. Receives: Procedure: Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. |
| Pulsed field ablation performed under fluoroscopic guidance | Active comparator | Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. Receives: Procedure: Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of complete electrical isolation of pulmonary veins during the procedure
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
Measured: Immediately post-procedure
Secondary outcomes (11)
The incidence of complications within 30 days after the procedure
Observe the proportion of complications occurring within 30 days after the procedure. Such complications include pericardial effusion or cardiac tamponade requiring drainage, phrenic nerve palsy lasting more than 24 hours, severe vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death.
Measured: Within 30 days post-procedure
Success rate of atrial fibrillation ablation at 12 months post-procedure.
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
Measured: 12 months post-procedure
The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
Measured: 12 months post-procedure
The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure
The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure.
Measured: 12 months post-procedure
The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
Measured: 12 months post-procedure
The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
Measured: From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline
The degree of improvement in total EQ-5D scores at 12 months after ablation relative to baseline levels
Measured: 12 months post-procedure
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Measured: Immediately post-procedure
Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups.
After hospital discharge, the length of hospital stay for this admission and the duration of postoperative observation in CCU/ICU were compared between the two groups of patients.
Measured: through study completion, an average of 1 year
Compare the procedural time and DSA fluoroscopy time between the two groups.
Statistical analyses were performed to compare procedural duration and DSA fluoroscopy duration across the two groups.
Measured: Immediately post-procedure
Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses.
Total hospitalization costs incurred during this admission were compared between the two groups after hospital discharge.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
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.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Hangzhou Dinova EP Technology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762742
- Sponsor's protocol ID
- 2026-3078
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07762742
- Acronym / sponsor ID
- 2026-3078
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Hangzhou Dinova EP Technology Co., Ltd
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 13 Aug 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 prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous pulsed field ablation performed under ultrasound-only guidance. | Experimental | Procedure: Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. |
| Pulsed field ablation performed under fluoroscopic guidance | Active comparator | Procedure: Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 to 75 years (including 18 years and 75 years of age).
- Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation.
- Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Key exclusion criteria (9 listed)
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes;
- Previous history of catheter ablation or cardiac surgery for atrial fibrillation;
- Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair;
- Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials;
- Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.);
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 |
|---|---|---|
| Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. | Procedure or surgery | Percutaneous pulsed field ablation performed under ultrasound-only guidance. |
| Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. | Procedure or surgery | Pulsed field ablation performed under fluoroscopic guidance |
Primary outcome
Success rate of complete electrical isolation of pulmonary veins during the procedure
Time frame: Immediately post-procedure
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
11 secondary outcomes
The incidence of complications within 30 days after the procedure
Time frame: Within 30 days post-procedure
Success rate of atrial fibrillation ablation at 12 months post-procedure.
Time frame: 12 months post-procedure
The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
Time frame: 12 months post-procedure
The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure
Time frame: 12 months post-procedure
The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
Time frame: 12 months post-procedure
The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
Time frame: From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline
Time frame: 12 months post-procedure
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Time frame: Immediately post-procedure
Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups.
Time frame: through study completion, an average of 1 year
Compare the procedural time and DSA fluoroscopy time between the two groups.
Time frame: Immediately post-procedure
Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses.
Time frame: through study completion, an average of 1 year
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 Aug 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.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. and Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. in people with Paroxysmal Atrial Fibrillation (PAF), run by China National Center for Cardiovascular Diseases.
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 3 inclusion and 9 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 Aug 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 MIN TANG, Doctor (86+ 13810665178, doctordangmin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of complete electrical isolation of pulmonary veins during the procedure (time frame: Immediately post-procedure). 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 Aug 2026.