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Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems (MICROPFA)

21. mai 2026 oppdatert av: Ivan Zeljkovic

Cerebral Microembolization During Pulmonary Vein Isolation: a Randomized Comparison of Different Pulsed Field Ablation Systems

This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent atrial fibrillation. Adult patients with an indication for catheter ablation will be randomized to one of the included ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. Microembolic signals will be assessed using transcranial Doppler before and after the procedure. The primary outcome will be the difference in the change in microembolic signal burden, expressed as ΔMES, between the different ablation systems.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study is designed as a prospective, randomized, parallel-group interventional trial conducted at Clinical Hospital Dubrava, Zagreb, Croatia and University Hospital Center Sisters of Charity, Zagreb, Croatia. The study will include adult patients with paroxysmal or persistent atrial fibrillation who have a clinical indication for catheter ablation with pulmonary vein isolation.

Eligible patients will be randomized using a computer-generated randomization sequence to undergo pulmonary vein isolation with one of the following pulsed field ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. All procedures will be performed according to standard clinical practice, with continuous periprocedural anticoagulation in accordance with current guidelines.

Cerebral microembolization will be assessed using transcranial Doppler. The examination will be performed immediately before the ablation procedure and repeated after the procedure. The presence and number of microembolic signals will be recorded. This will allow assessment of changes in microembolic signal burden within each group and comparison of these changes between different pulsed field ablation systems.

Demographic, clinical, and procedural data will be collected, including age, sex, type of atrial fibrillation, comorbidities, procedure duration, number of ablation applications, and procedural complications. The study will also record procedure-related clinical neurological events.

The primary outcome will be the difference in the change in the number of microembolic signals before and after the procedure, expressed as ΔMES, between the different pulsed field ablation systems. Secondary outcomes will include within-group changes in microembolic signal burden, incidence of new microembolic signals after the procedure, association between procedural parameters and ΔMES, and occurrence of procedure-related neurological events.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kroatia
      • Zagreb, Kroatia, 10000
        • UH Dubrava
        • Hovedetterforsker:
          • Ivan Zeljković, MD, Phd
        • Underetterforsker:
          • Mihovil Santini, MD
      • Zagreb, Kroatia, 10000
        • University Hospital Center Sisters of Charity, Zagreb, Croatia

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:

  • Age 18 years or older
  • Paroxysmal or persistent atrial fibrillation
  • Indication for catheter ablation with pulmonary vein isolation
  • Feasibility of transcranial Doppler assessment
  • Signed informed consent

Exclusion Criteria:

  • Recent stroke or transient ischemic attack
  • Significant cerebrovascular disease preventing reliable transcranial Doppler assessment
  • Severe valvular or structural heart disease
  • Pregnancy or breastfeeding
  • Inability to receive anticoagulation

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
Aktiv komparator: PulseSelect PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the PulseSelect pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Enhet: Pulsed field ablation using PulseSelect system
Pulmonary vein isolation will be performed using the PulseSelect pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Aktiv komparator: Varipulse PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Varipulse pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Enhet: Pulsed field ablation using Varipulse system
Pulmonary vein isolation will be performed using the Varipulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Aktiv komparator: Farapulse PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Farapulse pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Enhet: Pulsed field ablation using Farapulse system
Pulmonary vein isolation will be performed using the Farapulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedu
Aktiv komparator: Sphere-9 PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-9 pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Enhet: Pulsed field ablation using Sphere-9 system
Pulmonary vein isolation will be performed using the Sphere-9 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
Aktiv komparator: Sphere-360 PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-360 pulsed field ablation system. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure
Enhet: Pulsed field ablation using Sphere-360 system
Pulmonary vein isolation will be performed using the Sphere-360 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation. Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in microembolic signal burden after pulmonary vein isolation
Tidsramme: During procedure
Difference in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation, expressed as ΔMES, compared between the different pulsed field ablation systems.
During procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Within-group change in microembolic signal burden
Tidsramme: During procedure
Change in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation within each pulsed field ablation system group.
During procedure
Incidence of new microembolic signals after ablation
Tidsramme: Immediately after the ablation procedure
Proportion of participants with newly detected cerebral microembolic signals on transcranial Doppler after pulmonary vein isolation.
Immediately after the ablation procedure
Procedure-related clinical neurological events
Tidsramme: From the start of the ablation procedure through 72 hours after the procedure
Occurrence of clinically evident neurological events related to the ablation procedure, including stroke or transient ischemic attack.
From the start of the ablation procedure through 72 hours after the procedure
Association between procedure duration and ΔMES
Tidsramme: During procedure
Association between total procedure duration and the change in cerebral microembolic signal burden before and after pulmonary vein isolation.
During procedure
Association between number of ablation applications and ΔMES
Tidsramme: During procedure
Association between the number of pulsed field ablation applications delivered during pulmonary vein isolation and the change in cerebral microembolic signal burden before and after the procedure.
During procedure

Samarbeidspartnere og etterforskere

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

Sponsor

Ivan Zeljkovic

Samarbeidspartnere

University Hospital Dubrava
University Hospital Center Sisters of Charity, Zagreb, Croatia

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 (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

20. januar 2027

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026/0423-11

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