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NCT Number: NCT07762742

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation (PAF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

MIN TANG, Doctor

CONTACT

[email protected]

86+ 13810665178

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Hangzhou Dinova EP Technology Co., Ltd

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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