A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
11 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
276
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: MIN TANG, Doctor
- Numero di telefono: 86+ 13810665178
- Email: doctordangmin@sina.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: Pulsed field ablation performed under fluoroscopic guidance
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
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Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Success rate of complete electrical isolation of pulmonary veins during the procedure
Lasso di tempo: Immediately post-procedure
|
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
|
Immediately post-procedure
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The incidence of complications within 30 days after the procedure
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 agosto 2026
Completamento primario (Stimato)
28 febbraio 2029
Completamento dello studio (Stimato)
28 febbraio 2029
Date di iscrizione allo studio
Primo inviato
29 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 agosto 2026
Primo Inserito (Effettivo)
13 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 agosto 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-3078
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .