A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
August 11, 2026 updated by: China National Center for Cardiovascular Diseases
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
276
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MIN TANG, Doctor
- Phone Number: 86+ 13810665178
- Email: doctordangmin@sina.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Percutaneous pulsed field ablation performed under ultrasound-only guidance.
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.
|
|
Active Comparator: Pulsed field ablation performed under fluoroscopic 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of complications within 30 days after the procedure
Time Frame: Within 30 days post-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.
|
Within 30 days post-procedure
|
|
Success rate of atrial fibrillation ablation at 12 months post-procedure.
Time Frame: 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)
|
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 admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
|
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 who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure.
|
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 undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
|
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
|
The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
|
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
|
The degree of improvement in total EQ-5D scores at 12 months after ablation relative to baseline levels
|
12 months post-procedure
|
|
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
Time Frame: Immediately post-procedure
|
Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
|
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
|
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.
|
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
|
Statistical analyses were performed to compare procedural duration and DSA fluoroscopy duration across the two groups.
|
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
|
Total hospitalization costs incurred during this admission were compared between the two groups after hospital discharge.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 15, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2029
Study Registration Dates
First Submitted
July 29, 2026
First Submitted That Met QC Criteria
August 11, 2026
First Posted (Actual)
August 13, 2026
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-3078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.