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Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) (POWER-AF)

24 maggio 2026 aggiornato da: China National Center for Cardiovascular Diseases

Pulsed Field Ablation for Atrial Fibrillation Including Posterior Wall and Linear Ablation: A Randomized Controlled Trial of Safety and Efficacy (POWER-AF)

Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. As of 2019, there were approximately 59.7 million patients with AF worldwide, including atrial flutter (AF). Atrial fibrillation can significantly increase the risks of stroke, thromboembolism and heart failure in patients, seriously affecting their quality of life.

Catheter ablation is the main means for rhythm control in patients with atrial fibrillation. A large number of clinical studies have confirmed the effectiveness and safety of catheter ablation for atrial fibrillation. It is significantly superior to drug treatment in maintaining sinus rhythm and can significantly improve symptoms and quality of life.

Pulsed electric field ablation (PFA) is a novel ablation method that utilizes pulsed electric fields as energy. It uses multiple short-duration and high-voltage electrical pulses to release ablation energy, selectively causing myocardial cells to rupture and die. However, it has no obvious damaging effect on blood vessels, nerves, and tissues around the heart, such as the lungs, esophagus, and phrenic nerve.

This trial was designed based on the advantage of the characteristic that PFA does not damage the esophagus, confining the damage to the posterior half of the left atrium and the circumferential isthmus of the mitral valve. While improving the ablation success rate, it is possible to protect the function of the left atrium. This study aims to verify the superiority of the new rhythm control strategy in a large-scale population by launching a prospective randomized controlled trial.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1574

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

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100037
        • Reclutamento
        • National Cardiovascular Diseases Center, Fuwai Hospital
        • Contatto:

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:

  1. Atrial fibrillation patients who will accept catheter ablation.
  2. Age ≥ 18.
  3. Be capable of understanding and signing the informed consent form.

Exclusion Criteria:

  1. Have contraindications for catheter ablation (such as atrial thrombosis, decompensated heart failure, etc.)
  2. Have accepted catheter ablation before.
  3. Myocardial infarction, or any cardiac interventional/surgery has been performed within 3 months.
  4. Had a stroke or transient ischemic attack within 6 months.
  5. Allergy to iodine contrast agents.
  6. Participate in clinical trials related to other drugs or devices.
  7. Pregnant women, lactating women, or women with plans to become pregnant shortly.
  8. Active stage of infection.
  9. Secondary atrial fibrillation, such as combined with rheumatic heart disease, hypertrophic cardiomyopathy, etc.
  10. Patients who do not agree to be enrolled or are unable to cooperate to complete the 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: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Pulsed Field Ablation Arm
Procedura: Pulsed field ablation
Left atrial electrical anatomical mapping modeling was performed using a high-density mapping catheter, and ablation was carried out using a pulsed field catheter. For patients with paroxysmal atrial fibrillation, bilateral large loop pulmonary vein isolation combined with left posterior atrial wall ablation is performed. For patients with persistent atrial fibrillation, bilateral large loop pulmonary vein isolation, left posterior atrial wall ablation, and mitral valve isthmus ablation are performed. For patients with atrial fibrillation rhythm after ablation, intravenous ibutilide/electrical cardioversion was used for conversion, and the specific conversion strategy was consistent with that of the radiofrequency ablation group.
Dispositivo: Pulsed field ablation system
Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.
Comparatore attivo: Radiofrequency Ablation Arm
Procedura: Radiofrequency ablation alone
Radiofrequency ablation will be performed using a saline perfusion catheter, and the ablation catheter was empirically selected by the surgeon. For patients with paroxysmal atrial fibrillation, circumferential pulmonary vein isolation is performed. For patients with persistent atrial fibrillation, circumferential pulmonary vein isolation combined with individualized linear ablation is performed. For those whose ablation of all the established routes has been completed but whose sinus rhythm has not been restored, intravenous ibulide is used for drug cardioversion. If the drug fails to counteract, perform two-phase alternating current cardioversion. Cardioversion can be repeated at most twice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recurrence of atrial fibrillation within 12 months after ablation
Lasso di tempo: 12 months after ablation
Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after the post-ablation blanking period, documented by 12-lead electrocardiogram, Holter monitoring, event recorder, or other rhythm monitoring methods.
12 months after ablation

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in atrial fibrillation burden from baseline to 12 months after ablation
Lasso di tempo: Baseline and 12 months after ablation
Change in atrial fibrillation burden among participants with paroxysmal atrial fibrillation. Atrial fibrillation burden is defined as the percentage of monitored time spent in atrial fibrillation during rhythm monitoring.
Baseline and 12 months after ablation
Change in left ventricular ejection fraction from baseline to 12 months after ablation
Lasso di tempo: Baseline and 12 months after ablation
Change in left ventricular ejection fraction measured by echocardiography. Unit of Measure: Percentage points
Baseline and 12 months after ablation
Change in 36-Item Short Form Health Survey physical component summary score from baseline to 12 months after ablation
Lasso di tempo: Baseline and 12 months after ablation
Change in quality of life assessed using the physical component summary score of the 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better physical health status.
Baseline and 12 months after ablation
All-cause mortality within 12 months after ablation
Lasso di tempo: 12 months after ablation
Death from any cause during the 12-month follow-up period after ablation. Unit of Measure: Number or percentage of participants
12 months after ablation
Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation
Lasso di tempo: Baseline and 12 months after ablation
Change in quality of life assessed using the mental component summary score of the 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better mental health status.
Baseline and 12 months after ablation

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

China National Center for Cardiovascular Diseases

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 (Effettivo)

16 aprile 2025

Completamento primario (Stimato)

30 novembre 2027

Completamento dello studio (Stimato)

30 novembre 2028

Date di iscrizione allo studio

Primo inviato

8 maggio 2025

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-2569

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

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

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 .

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