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

3 novembre 2026 mis à jour par: 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)

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

124

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
    • Isère
      • Grenoble, Isère, France, 38000
        • Chu Grenoble Alpes
        • Chercheur principal:
          • Pascal DEFAYE, Pr
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Sandrine VENIER, Dr
        • Sous-enquêteur:
          • Peggy JACON, Dr
        • Sous-enquêteur:
          • Adrien CARABELLI, Dr
    • Rhone
      • Bron, Rhone, France, 69500
        • Hopital Louis Pradel
        • Contact:
        • Contact:
        • Chercheur principal:
          • Philippe CHEVALIER, Pr
        • Sous-enquêteur:
          • Kevin GARDEY, Dr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Standard of care

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

patient treated with inhaled hydrogen therapy during the perioperative period
Médicament: 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)

Autres noms:
  • inhaled hydrogen therapy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Effectiveness of inhaled hydrogen therapy on early recurrences of atrial fibrillation post-ablation and on the improvement of quality of life at 3 months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of hospitalizations or electrical cardioversions or pharmacological cardioversions during the blanking period (3 months)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: Day 2 after ablation

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Grenoble

Collaborateurs

University Grenoble Alps

Les enquêteurs

  • Chercheur principal: Pascal DEFAYE, Pr, CHU Grenoble Alpes

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

1 janvier 2029

Achèvement de l'étude (Estimé)

1 septembre 2029

Dates d'inscription aux études

Première soumission

2 juin 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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