Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

13. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

292

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

  • Grækenland
      • Athens, Grækenland
        • Rekruttering
        • Hygeia Hospital, 8th Cardiology Department
        • Kontakt:
          • Stylianos Tzeis, MD, PhD, FEHRA
          • Telefonnummer: +302106869777
          • E-mail: stzeis@otenet.gr
  • Italien
      • Ancona, Italien
        • Ikke rekrutterer endnu
        • Marche Polytechnic University / Marche University Hospital
        • Kontakt:
  • Kroatien
      • Zagreb, Kroatien
        • Ikke rekrutterer endnu
        • University Hospital Centre Zagreb (KBC Zagreb)
        • Kontakt:
  • Polen
      • Warsaw, Polen
        • Ikke rekrutterer endnu
        • Grochowski Hospital, Centre of Postgraduate Medical Education
        • Kontakt:
  • Slovakiet
      • Banská Bystrica, Slovakiet
        • Ikke rekrutterer endnu
        • Department of Arrhythmology, Institute of Cardiovascular Diseases
        • Kontakt:
  • Slovenien
      • Ljubljana, Slovenien
        • Ikke rekrutterer endnu
        • University Medical Centre Ljubljana (UKC Ljubljana)
        • Kontakt:
  • Tjekkiet
      • Prague, Tjekkiet
        • Ikke rekrutterer endnu
        • Department of Cardiology, IKEM
        • Kontakt:
  • Ungarn
      • Budapest, Ungarn
        • Ikke rekrutterer endnu
        • Heart and Vascular Center, Semmelweis University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: ICE
Intracardiac echocardiography-guided group
Andet: 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.
Andet: Mapping
Three-dimensional electroanatomical mapping-guided group
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mitera Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

10. august 2026

Først indsendt, der opfyldte QC-kriterier

13. august 2026

Først opslået (Faktiske)

19. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-06-2026 677

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner