A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
11. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
276
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: MIN TANG, Doctor
- Telefonnummer: 86+ 13810665178
- E-post: doctordangmin@sina.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Success rate of complete electrical isolation of pulmonary veins during the procedure
Tidsramme: Immediately post-procedure
|
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
|
Immediately post-procedure
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The incidence of complications within 30 days after the procedure
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
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Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
15. august 2026
Primær fullføring (Antatt)
28. februar 2029
Studiet fullført (Antatt)
28. februar 2029
Datoer for studieregistrering
Først innsendt
29. juli 2026
Først innsendt som oppfylte QC-kriteriene
11. august 2026
Først lagt ut (Faktiske)
13. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-3078
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