A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation

NCT07762742 | Not Yet Recruiting

• 1 other identifier: 2026-3078
• Study Type: interventional
• Target: 276
• Locations: 0 countries
• Sites: N/A

Brief 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). 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately post-procedure

Secondary Outcomes (11)

• The incidence of complications within 30 days after the procedure

  Within 30 days post-procedure

• Success rate of atrial fibrillation ablation at 12 months post-procedure.

  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

  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

Study Arms (2)

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.

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.

Procedure: Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.

Interventions

Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. PROCEDURE

Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.

Percutaneous pulsed field ablation performed under ultrasound-only guidance.

Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. PROCEDURE

Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.

Pulsed field ablation performed under fluoroscopic guidance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Hangzhou Dinova EP Technology Co., Ltd: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MIN TANG, Doctor

CONTACT

86+ 13810665178; doctordangmin@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share