Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

276

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.
Actieve vergelijker: Pulsed field ablation performed under fluoroscopic 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.
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Success rate of complete electrical isolation of pulmonary veins during the procedure
Tijdsspanne: Immediately post-procedure
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
Immediately post-procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence of complications within 30 days after the procedure
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China National Center for Cardiovascular Diseases

Medewerkers

Hangzhou Dinova EP Technology Co., Ltd

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 augustus 2026

Primaire voltooiing (Geschat)

28 februari 2029

Studie voltooiing (Geschat)

28 februari 2029

Studieregistratiedata

Eerst ingediend

29 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 augustus 2026

Eerst geplaatst (Werkelijk)

13 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

11 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-3078

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren