Hydrogen for Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Be over 18 years of age\n- Have paroxysmal or persistent AF with symptoms lasting less than 6 months\n- Be a candidate for first-time AF ablation (cryoablation, electroporation)\n- Understand and agree to comply with the study procedures\n- Have a smartphone\n- Be enrolled in a social security program or have similar rights\n- Have signed the study consent form"}

Exclusion criteria

• {"criterion_text":"- Be over 80 years of age\n- Persons referred to in Articles L1121-5 to L1121-8 of the CSP and Articles 31 to 35 of Regulation 536/2014 (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of their liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care institution for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent).\n- Personnel with a hierarchical relationship with the principal investigator\n- Have a left atrial diameter ≥ 50 mm on TEE.\n- Have a history of AF ablation.\n- Radiofrequency ablation.\n- Patient undergoing long-term anti-inflammatory treatment.\n- Patients with gas administration equipment (CPAP, NIV, etc.)\n- Women of childbearing potential\n- Uncooperative patients\n- During exclusion period from another study"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite binary endpoint: (1) absence of early recurrence during the 3-month blanking period, where recurrence is any episode of AF, atrial flutter, or atrial tachycardia lasting ≥ 30 seconds; AND (2) improvement in QoL defined as a decrease in AFEQT score ≥ 5 points between day 0 (D0) and month 3 (M3)."}

Secondary endpoints

• {"endpoint_text":"- Number of hospitalizations or electrical cardioversions or drug-induced cardioversions during the blanking period","definition_or_measurement_approach":"Count of hospitalizations and cardioversions (electrical or drug-induced) occurring during the 3-month blanking period."}
• {"endpoint_text":"- Late recurrence (> 3 months and up to 12 months after ablation)","definition_or_measurement_approach":"Occurrence of AF recurrence occurring >3 months and up to 12 months post-ablation."}
• {"endpoint_text":"- Variation in blood concentration of inflammation markers (GB, CRPus, and IL-6) between 24 hours pre-ablation and 24–48 hours post-ablation","definition_or_measurement_approach":"Change in blood levels of white blood cells (GB), high-sensitivity CRP (CRPus), and IL-6 between 24 hours before ablation and 24–48 hours after ablation."}
• {"endpoint_text":"- Collection of adverse events that will be described and graded using the Common Terminology Criteria for Adverse Events v5.0 (CTCAE) terminology.","definition_or_measurement_approach":"All adverse events collected and described; severity graded according to CTCAE v5.0."}
• {"endpoint_text":"- Customized questionnaire on patient acceptance of hydrogen therapy treatment upon admission to the hospital (part 1) and upon discontinuation of hydrogen therapy (part 2)","definition_or_measurement_approach":"Patient-reported acceptability assessed using a bespoke questionnaire administered at hospital admission and at discontinuation of hydrogen therapy."}
• {"endpoint_text":"- Customized hetero-questionnaire on healthcare providers' acceptance of hydrogen therapy treatment","definition_or_measurement_approach":"Healthcare provider acceptability assessed using a bespoke hetero-questionnaire."}

France

Earliest CTIS Part Ii Submission Date

08-12-2025

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

79

Number Of Sites

2

Number Of Participants

136

Primary sponsor

Full Name

Centre Hospitalier Universitaire Grenoble Alpes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"DGOS (French Health Ministry)","duties_or_roles":"Source of monetary support","organisation_type":"Government"}