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Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation?

5. september 2020 oppdatert av: Hong Euy Lim, MD, Korea University Guro Hospital

Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation? (The VEGA-AF Study)

This study is designed to investigate whether pulmonary vein isolation(PVI) plus stepwise additional ablation approach based on the degree of low voltage area versus PVI only can improve procedure outcome in persistent atrial fibrillation(AF) patients.

Studieoversikt

Detaljert beskrivelse

Catheter ablation of AF is well accepted and widely performing treatment method of AF at present. Pulmonary vein isolation (PVI) which aims to electrical isolation of pulmonary veins is currently the standard therapy for AF. But some researchers proposed additional ablation strategy for persistent AF (PeAF) because abnormal atrial substrate may play a role in these patients.

However, there are inconsistent reports regarding a success rate of additional catheter ablation methods other than PVI. Thus, there still is no consensus on which strategy is appropriate in addition to PVI. One of these proposed options is complex fractioned atrial electrograms (CFAE) ablation. A meta-analysis of controlled trials comparing PVI alone versus PVI with CFAE reported that the addition of CFAE ablation results in a statistically significant increase in success rate for PeAF patients. Conversely, a prospective multicenter trial, The Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR-AF II) trial showed that recurrence rate of AF following catheter ablation treatment was not significantly reduced when either linear ablation or ablation of CFAE was performed in addition to PVI. The investigators have previously reported that posterior wall isolation in addition to PVI plus linear lesions reduced recurrence of AF following catheter ablation compared to PVI only but the long-term success rate were markedly lower in the CFAE-guide ablation in addition PVI plus linear lesions group than in PVI plus linear lesions group among PeAF patients. Although benefit of addition CFAE could be originated from modification of abnormal atrial substrate which is generated by structural and electrical remodeling, this possible benefit could be counterbalanced by increased formation of transmural ablation scar which may result in dysfunction of left atrium and recurrence of atrial tachyarrhythmia. A recent study have showed that extent of myocardial injury by catheter ablation was associated with left atrium functional deterioration in patients with paroxysmal AF and myocardial damage provoked that may contribute to recurrence of AF following catheter ablation.

Therefore, identification of PeAF patients who would benefit from additional ablation and tailored stepwise approach based on the identification may lead to reduction of iatrogenic myocardial injury and optimization of the result for the AF catheter ablation.

Recent data have shown that voltage guided mapping of left atrium is a powerful predictor of AF recurrence after PAI and voltage based ablation strategy showed promising result in terms of tailored approach. But, prospective, randomized clinical studies are needed to compare the result of a voltage-based AF ablation to the result of established strategies.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

      • Bucheon, Korea, Republikken, 14754
        • Bucheon Sejong Hospital
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republikken, 08308
        • Korea University Guro Hospital
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, Korea, Republikken, 02841
        • Korea University Anam Hospital

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

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients undergoing first-time catheter ablation for AF.
  • Willing and able to provide informed consent
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • Patients who have previously undergone AF ablation
  • Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement
  • Patients with chronic renal impairment with creatinine clearance rate of <30 mL/min
  • Patients who are pregnant

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: Additional posterior wall isolation
Operator will perform pulmonary vein isolation (PVI) and additional posterior wall isolation if low voltage area exists more than 10% of the left atrium

PVI and additional posterior wall isolation will be performed according to the following protocol which is based on low voltage area.

  1. Proportion of low voltage area to area of left atrium body <10% : PVI only
  2. Proportion of low voltage area to area of left atrium body ≥10% : PVI + Posterior wall isolation

    • Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).
Eksperimentell: Voltage-guided substrate homogenization
Operator will perform pulmonary vein antrum isolation (PVI) and additional substrate modification based on the degree of low voltage area.

PVI and additional substrate modification at low voltage areas will be performed according to the following protocol which is based on low voltage area.

  1. Proportion of low voltage area to area of left atrium body <10% : PVI only
  2. Proportion of low voltage area to area of left atrium body ≥10% : PVI + substrate homogenization at low voltage areas

    • Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).
Aktiv komparator: PVI only group
Operator will perform PVI only
PVI will be performed in this arm.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure
Tidsramme: Within 1 year after the ablation procedure

Any recurrence of ECG or Holter documented atrial tachyarrhythmia*

* Sustained AF or atrial tachycardia >30 s duration.

Within 1 year after the ablation procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Procedure related complication rate
Tidsramme: during procedure and follow-up period(up to 1 year)
any adverse events
during procedure and follow-up period(up to 1 year)
Total procedural time
Tidsramme: During procedure
total cumulative amount of radiation exposure
During procedure

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Hong Euy Lim, MD, Ph.D., Professor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

15. februar 2018

Primær fullføring (Faktiske)

15. desember 2019

Studiet fullført (Faktiske)

15. desember 2019

Datoer for studieregistrering

Først innsendt

9. desember 2017

Først innsendt som oppfylte QC-kriteriene

14. desember 2017

Først lagt ut (Faktiske)

19. desember 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2020

Sist bekreftet

1. september 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • KUGH17287 (VEGA-AF)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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