Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation.
Key facts
- Where
- Bron és Grenoble Cedex 9, FranciaországSee the 2 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Forrás: NCT07928622: ki vehet részt
Where in Franciaország
- Hospices Civils de LyonBron, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT07928622EU 2024-520131-33-00
- Record updated
- 2026. november 10.
- Original description
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.Read full original descriptionShow less
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)
Inclusion: Be over 18 years old; Present with paroxysmal or persistent Atrial Fibrilation (AF) of less than 6 months with symptoms; Be a candidate for a first-time AF ablation (cryoablation and electroporation); Understand and agree to comply with the study procedures; Patient must have a smartphone; Be enrolled in a social security scheme, or have equivalent rights; Have signed the study consent form.
Exclusion: 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); Having a history of AF ablation; Being over 80 years old; Having a left atrial diameter ≥ 50mm on transthoracic echocardiography; Radiofrequency ablation; Patient on long-term anti-inflammatory treatment; Patient with gas administration equipment (CPAP, NIV…); Woman of childbearing potential*; Non-cooperative patient; In the exclusion period for another study; Staff with a hierarchical relationship with the principal investigator.