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VOLta Medical AI-software in REal-World During AF Ablation (VOLTAIRE-AF)

17. juni 2026 oppdatert av: Volta Medical

Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies

This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in "real life"clinical practice, without any imposed clinical workflow.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Enhet: Cardiac mapping

Detaljert beskrivelse

All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II) during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to standard practice. Intraoperative and postoperative follow-up will be performed as in routine clinical practice during AF ablation procedures: hospitalization for ablation procedure and standard postoperative quarterly visits (at 3 months, at 6 months and/or 9 months as per the study investigator's Standard Of Care) then annual visits up to 24 months post-ablation. Adverse Events, recurrences of atrial arrhythmia, Heart Failure related symptom score ("NYHA") and AF related symptoms (EHRA score) are collected from the patient's enrollment until the patient's study termination. A quality-of-life questionnaire related to general health (EQ-5D-3L) is collected during the preoperative visit and at least during annual follow-up visits. The patient's study-termination corresponds to the last annual visit at 24 months post-ablation index.

Studietype

Observasjonsmessig

Registrering (Antatt)

150

Kontakter og plasseringer

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

Studiekontakt

Navn: Paola MILPIED
Telefonnummer: +33768025499
E-post: paola.milpied@volta-medical.com

Studer Kontakt Backup

Navn: Cécile BIELMANN
E-post: cecile.bielmann@volta-medical.com

Studiesteder

Frankrike
- - Marseille, Frankrike, 13008
    - Rekruttering
    - Hôpital Saint-Joseph Marseille
    - Ta kontakt med:
      
      Clément BARS, MD
  - Saint-Denis, Frankrike, 93207
    - Har ikke rekruttert ennå
    - Centre Cardiologique du Nord
    - Ta kontakt med:
      
      Antoine Lepillier, MD
  - Strasbourg, Frankrike, 67000
    - Har ikke rekruttert ennå
    - Clinique Rhéna
    - Ta kontakt med:
      
      Babé BAKOUBOULA, MD

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All adult patient candidate eligible for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.

Beskrivelse

Inclusion Criteria:

Patient aged 18 years or older.
Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.
Patient able and willing to provide written informed consent to participate in the study.
Only for France: Patient affiliated to the French social security system.

Exclusion Criteria:

Contraindication to AF/AT catheter ablation using RF and/or PFA.
Patient who is or could potentially be pregnant.
Person deprived of liberty or under guardianship.
Person unable to undergo a medical monitoring for geographical, social or psychological reasons.
Patient's refusal to participate in the study.
Enrollment in a premarket clinical study evaluating device, drug or biologic product.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, at 12 and 24 months. Tidsramme: 24 months	An Atrial Arrhythmia episode (AF/AFL/AT ≥ 30s) will be determined to be clinically significant if it results in an unexpected treatment change (e.g. new anti-arrhythmic drug or higher dose of AAD, repeat ablation procedure, DC cardioversion), or if it is accompanied by worsening of symptoms related to AF, considering a standard 3-month blanking period.	24 months
Volta AF-Xplorer II-related Serious Incident rate Tidsramme: 24 months		24 months
Ablation procedure-related Serious Adverse Event rate Tidsramme: 24 months		24 months

Sekundære resultatmål

Resultatmål	Tidsramme
Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). Tidsramme: 24 months	24 months
Progression of the AF related symptom score ("EHRA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). Tidsramme: 24 months	24 months
Progression of the Heart Failure related symptom score ("NYHA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). Tidsramme: 24 months	24 months
Hospitalization rate during the post-ablation follow-up period. Tidsramme: 24 months	24 months
Serious Adverse Event rate during the post-ablation follow-up period. Tidsramme: 24 months	24 months
Average number of ablation procedures per patient up to 24 months follow-up. Tidsramme: 24 months	24 months
Average number of cardioversions per patient up to 24 months follow-up Tidsramme: 24 months	24 months
Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study. Tidsramme: 24 months	24 months
Health economics analysis including QALY metric Tidsramme: 24 months	24 months

Samarbeidspartnere og etterforskere

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

Sponsor

Volta Medical

Etterforskere

Hovedetterforsker: Clément BARS, MD, Hôpital Saint Joseph Marseille

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)

16. juni 2026

Primær fullføring (Antatt)

1. juni 2030

Studiet fullført (Antatt)

1. juni 2030

Datoer for studieregistrering

Først innsendt

27. mai 2026

Først innsendt som oppfylte QC-kriteriene