interventional
N/A
1 country
2
To study the efficacy of inhaled hydrogen therapy on early recurrence of atrial fibrillation after ablation and improvement of quality of life at 3 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2025
Actual (reported)The primary endpoint is binary and composite, defined as: - The absence of early recurrence during the blanking period (3 months post-ablation), defined as any episode of AF, atrial flutter, or atrial tachycardia lasting at least 30 seconds AND - Improvement in quality of life defined as a decrease in the AFEQT (Atrial Fibrillation Effect on Quality of Life) score of at least 5 points (72) between D0 and M3.
Number of hospitalizations or electrical cardioversions or drug-induced cardioversions during the blanking period
Late recurrence (> 3 months and up to 12 months after ablation)
Variation in blood concentration of inflammation markers (GB, CRPus, and IL-6) between 24 hours pre-ablation and 24–48 hours post-ablation
Collection of adverse events that will be described and graded using the Common Terminology Criteria for Adverse Events v5.0 (CTCAE) terminology.
Customized questionnaire on patient acceptance of hydrogen therapy treatment upon admission to the hospital (part 1) and upon discontinuation of hydrogen therapy (part 2)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble Cedex 9, 38043, France
Hospices Civils De Lyon
Bron, 69500, France
First Submitted
October 28, 2025
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