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Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation. (H2-FA)

3. november 2026 oppdatert av: University Hospital, Grenoble

Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation. Phase II, Multicenter, Randomized, Controlled, Open-label Clinical Trial

The goal of this clinical trial is to testing the perioperative inhaled hydrogen (H2) administration's effects during atrial fibrillation ablations (AF) to reduce both early and late recurrences associated with this procedure.

Researchers will compare H2 inhalation to the standard of care to see if we observe a reduction in AF recurrence after ablation but also a reduction in rehospitalizations or emergency visits for cardioversion, and consequently an improvement in quality of life.

Participants will:

  • have an AF ablation associated to an hydrogen therapy or standard of care
  • complete quality of life questionnaires
  • record ECG on KardiaMobile©
  • Keep a diary of their symptoms
  • have a blood test
  • have 2 follow-up visits (after 3 and 12 months) and 2 phone calls (after 6 and 9 months)

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

124

Fase

  • Fase 2

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

  • Frankrike
    • Isère
      • Grenoble, Isère, Frankrike, 38000
        • Chu Grenoble Alpes
        • Hovedetterforsker:
          • Pascal DEFAYE, Pr
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Sandrine VENIER, Dr
        • Underetterforsker:
          • Peggy JACON, Dr
        • Underetterforsker:
          • Adrien CARABELLI, Dr
    • Rhone
      • Bron, Rhone, Frankrike, 69500
        • Hopital Louis Pradel
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Philippe CHEVALIER, Pr
        • Underetterforsker:
          • Kevin GARDEY, Dr

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Be over 18 years old
  2. Present with paroxysmal or persistent Atrial Fibrilation (AF) of less than 6 months with symptoms
  3. Be a candidate for a first-time AF ablation (cryoablation and electroporation)
  4. Understand and agree to comply with the study procedures
  5. Patient must have a smartphone
  6. Be enrolled in a social security scheme, or have equivalent rights
  7. Have signed the study consent form

Exclusion Criteria:

  1. Being over 80 years old
  2. Having a left atrial diameter ≥ 50mm on transthoracic echocardiography
  3. Radiofrequency ablation
  4. Having a history of AF ablation
  5. Patient on long-term anti-inflammatory treatment
  6. Patient with gas administration equipment (CPAP, NIV…)
  7. Woman of childbearing potential*
  8. Non-cooperative patient
  9. In the exclusion period for another study
  10. Persons covered by Articles L1121-5 to L1121-8 of the Public Health Code and Articles 31 to 35 of Regulation 536/2014 (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a healthcare or social facility for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent).
  11. Staff with a hierarchical relationship with the principal investigator

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Standard of care

patients treated with usual care (Standard of Care)
Eksperimentell: H2

patient treated with inhaled hydrogen therapy during the perioperative period
Legemiddel: Hydrogen Gas (H2)

Patients treated with inhaled hydrogen therapy in the perioperative period (initiation of inhaled hydrogen therapy from hospital admission until discharge, except in the operating room) (dosage : H2/N2 3.6%/96.4%, 1 L/min 24 hours a day)

Andre navn:
  • inhaled hydrogen therapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effectiveness of inhaled hydrogen therapy on early recurrences of atrial fibrillation post-ablation and on the improvement of quality of life at 3 months
Tidsramme: From baseline (before ablation) to 3 months after ablation

Composite binary endpoint, reported as the number of participants meeting both criteria: (1) no early recurrence during the blanking period (first 3 months after ablation), where recurrence is defined as any episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting at least 30 seconds; AND (2) improvement in quality of life, defined as an improvement in quality of life, defined as an increase of at least 5 points in the AFEQT overall score (range 0-100; higher scores indicate better quality of life) between baseline and 3 months.
From baseline (before ablation) to 3 months after ablation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of hospitalizations or electrical cardioversions or pharmacological cardioversions during the blanking period (3 months)
Tidsramme: From ablation to 3 months after ablation

Total number of hospitalizations or electrical cardioversions or pharmacological cardioversions occurring during the blanking period, i.e. the first 3 months after ablation. The three event types are summed into a single count per participant.
From ablation to 3 months after ablation
Incidence of Late Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence Between 3 and 12 Months After Ablation
Tidsramme: From 3 months to 12 months after ablation

Number of participants with late recurrence, defined as any episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting at least 30 seconds on Holter or Kardia recording, or recorded on a 12-lead electrocardiogram, occurring more than 3 months and up to 12 months after ablation.
From 3 months to 12 months after ablation
Change in White Blood Cell Count (WBC) from before ablation to 24 and 48 hours after ablation
Tidsramme: 24 hours before ablation, 24 hours after ablation, and 48 hours after ablation

Change in blood white blood cell (WBC) count, measured in 10^9 cells/L, between 24 hours before ablation and 24 hours and 48 hours after ablation.
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
Change in High-Sensitivity C-Reactive Protein (CRP) from before ablation to 24 and 48 hours after Ablation
Tidsramme: 24 hours before ablation, 24 hours after ablation, and 48 hours after ablation

Change in blood high-sensitivity C-reactive protein (hs-CRP) concentration, measured in mg/L, between 24 hours before ablation and 24 hours and 48 hours after ablation.
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
Change in Interleukin-6 from before ablation to 24 and 48 hours after Ablation
Tidsramme: 24 hours before ablation, 24 hours after ablation, and 48 hours after ablation

Change in blood interleukin-6 (IL-6) concentration, measured in pg/mL, between 24 hours before ablation and 24 hours and 48 hours after ablation.
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
Incidence of Adverse Events Graded by NCI-CTCAE Version 5.0 (Safety and Tolerability)
Tidsramme: From the start of inhaled hydrogen therapy to 12 months after ablation

Number of participants with adverse events, described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grades range from 1 (mild) to 5 (death related to adverse event); higher grades indicate more severe events.
From the start of inhaled hydrogen therapy to 12 months after ablation
Evaluate the acceptability of hydrogen therapy treatment by healthcare providers
Tidsramme: Day 2 after ablation

Custom hetero-questionnaire on the acceptability of hydrogen therapy treatment by healthcare providers
Day 2 after ablation

Samarbeidspartnere og etterforskere

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

Sponsor

University Hospital, Grenoble

Samarbeidspartnere

University Grenoble Alps

Etterforskere

  • Hovedetterforsker: Pascal DEFAYE, Pr, CHU Grenoble Alpes

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. januar 2027

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 38RC22.0404
  • 2024-520131-33-00 (Ctis)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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