Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

24. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1574

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100037
        • Rekruttering
        • National Cardiovascular Diseases Center, Fuwai Hospital
        • Ta kontakt med:

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:

  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

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Pulsed Field Ablation Arm
Fremgangsmåte: 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.
Enhet: 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.
Aktiv komparator: Radiofrequency Ablation Arm
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recurrence of atrial fibrillation within 12 months after ablation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in atrial fibrillation burden from baseline to 12 months after ablation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

China National Center for Cardiovascular Diseases

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. april 2025

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

30. november 2028

Datoer for studieregistrering

Først innsendt

8. mai 2025

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2024-2569

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere