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Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation (PFA-VISION)

13. august 2026 oppdatert av: Stylianos Tzeis, Mitera Hospital

Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)

This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

292

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: Stylianos Tzeis, MD, PhD, FEHRA
  • Telefonnummer: +302106869777
  • E-post: steis@otenet.gr

Studiesteder

  • Hellas
      • Athens, Hellas
        • Rekruttering
        • Hygeia Hospital, 8th Cardiology Department
        • Ta kontakt med:
          • Stylianos Tzeis, MD, PhD, FEHRA
          • Telefonnummer: +302106869777
          • E-post: stzeis@otenet.gr
  • Italia
      • Ancona, Italia
        • Har ikke rekruttert ennå
        • Marche Polytechnic University / Marche University Hospital
        • Ta kontakt med:
  • Kroatia
      • Zagreb, Kroatia
        • Har ikke rekruttert ennå
        • University Hospital Centre Zagreb (KBC Zagreb)
        • Ta kontakt med:
  • Polen
      • Warsaw, Polen
        • Har ikke rekruttert ennå
        • Grochowski Hospital, Centre of Postgraduate Medical Education
        • Ta kontakt med:
  • Slovakia
      • Banská Bystrica, Slovakia
        • Har ikke rekruttert ennå
        • Department of Arrhythmology, Institute of Cardiovascular Diseases
        • Ta kontakt med:
  • Slovenia
      • Ljubljana, Slovenia
        • Har ikke rekruttert ennå
        • University Medical Centre Ljubljana (UKC Ljubljana)
        • Ta kontakt med:
  • Tsjekkia
      • Prague, Tsjekkia
        • Har ikke rekruttert ennå
        • Department of Cardiology, IKEM
        • Ta kontakt med:
  • Ungarn
      • Budapest, Ungarn
        • Har ikke rekruttert ennå
        • Heart and Vascular Center, Semmelweis University
        • 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:

  • History of paroxysmal AF.
  • Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.

Exclusion Criteria:

  • Any contraindication to AF catheter ablation.
  • History of previous left atrial ablation.
  • Need for additional ablation beyond pulmonary vein isolation.
  • Inability to provide written informed consent.
  • Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.
  • eGFR < 30 mL/min/1.73 m2
  • NYHA class III/IV heart failure
  • Major cardiovascular events within 90 days
  • Secondary AF owing to reversible causes
  • Intracardiac thrombus or other conditions making left atrial instrumentation unsafe
  • Severe valvular disease

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
Annen: ICE
Intracardiac echocardiography-guided group
Annen: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.
Annen: Mapping
Three-dimensional electroanatomical mapping-guided group
Annen: In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping.
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Arrhythmia-free survival
Tidsramme: up to 12 months
Primary efficacy endpoint: Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after a blanking period of 2 months. A recurrence is defined as any episode of atrial tachyarrhythmia recorded on standard 12-lead ECG or any episode lasting ≥6 minutes on Holter monitor (or CIED with atrial sensing capabilities).
up to 12 months
Complications
Tidsramme: up to 12 months

Composite primary safety endpoint:

Number of participants experiencing at least one of the following prespecified complications (major safety events):

Stroke, transient ischemic attack, or systemic embolism Coronary spasm Myocardial infarction Cardiac tamponade Clinically relevant esophageal complication Clinically relevant pulmonary vein stenosis Diaphragmatic paralysis persisting for more than 6 months Acute kidney injury Bleeding requiring transfusion Major vascular complication Pericarditis or vagal nerve injury Heart failure or pulmonary edema Sudden death within 30 days of the procedure Any device- or procedure-related death

For the composite primary safety endpoint, each participant will be counted only once, regardless of the number or type of qualifying events experienced.
up to 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Arrhythmia-free survial (>30 sec)
Tidsramme: up to 12 months
Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) lasting >30 seconds on Holter monitoring, off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after an initial blanking period of 2 months.
up to 12 months
Procedure time (min)
Tidsramme: Periprocedural
Time from femoral puncture to catheter removal (minutes).
Periprocedural
Left atrial dwell time (min)
Tidsramme: Periprocedural
Time from transseptal puncture to catheter withdrawal from the left atrium (minutes).
Periprocedural
Number of lesions
Tidsramme: Periprocedural
Total number of ablation lesions deployed.
Periprocedural
Fluoroscopy time (min)
Tidsramme: Periprocedural
Duration of fluoroscopy (minutes).
Periprocedural
Fluoroscopy dose (cGy·cm²)
Tidsramme: Periprocedural
Total fluoroscopy dose (measured in cGy·cm²).
Periprocedural

Samarbeidspartnere og etterforskere

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

Sponsor

Mitera Hospital

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)

1. august 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

10. august 2026

Først innsendt som oppfylte QC-kriteriene

13. august 2026

Først lagt ut (Faktiske)

19. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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