Effect of H2 inhalation therapy on early recurrence after atrial fibrillation ablation.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-02-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS (French Health Ministry)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 6

1. To test the effect of inhaled hydrogen therapy on hospitalizations and cardioversions during the blanking period (3 months following AF ablation)
2. To test the effect of inhaled hydrogen therapy on late recurrence of AF (defined as up to 12 months post-ablation)
3. To test the effect of inhaled hydrogen therapy on markers of post-operative inflammation (GB, IL-6, and CRPus)
4. To evaluate the safety of inhaled hydrogen therapy in the perioperative period of AF ablation
5. To assess patient acceptability of hydrogen therapy treatment (H2 group)
6. To assess the acceptability of hydrogen therapy treatment by caregivers

Conditions and MedDRA coding

atrial fibrillation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 11

1. Be over 80 years of age
2. Have a left atrial diameter ≥ 50 mm on TEE.
3. Have a history of AF ablation.
4. Radiofrequency ablation.
5. Patient undergoing long-term anti-inflammatory treatment.
6. Patients with gas administration equipment (CPAP, NIV, etc.)
7. Women of childbearing potential
8. Uncooperative patients
9. During exclusion period from another study
10. 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).
11. Personnel with a hierarchical relationship with the principal investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 6

1. Number of hospitalizations or electrical cardioversions or drug-induced cardioversions during the blanking period
2. Late recurrence (> 3 months and up to 12 months after ablation)
3. Variation in blood concentration of inflammation markers (GB, CRPus, and IL-6) between 24 hours pre-ablation and 24–48 hours post-ablation
4. Collection of adverse events that will be described and graded using the Common Terminology Criteria for Adverse Events v5.0 (CTCAE) terminology.
5. Customized questionnaire on patient acceptance of hydrogen therapy treatment upon admission to the hospital (part 1) and upon discontinuation of hydrogen therapy (part 2)
6. Customized hetero-questionnaire on healthcare providers' acceptance of hydrogen therapy treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Grenoble Alpes

Sponsor organisation

Centre Hospitalier Universitaire Grenoble Alpes

Address

Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche

City

Grenoble Cedex 9

Postcode

38043

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Grenoble Alpes

Contact name

DEFAY

Public contact point

Organisation

Centre Hospitalier Universitaire Grenoble Alpes

Contact name

CHAMBON

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications