AuthorisedTherapeutic exploratory (Phase II)Interventional

Effect of H2 inhalation therapy on early recurrence after atrial fibrillation ablation. Multicenter, open-label, randomized phase II controlled trial.

This research is investigating if a new treatment, involving breathing a gas with hydrogen, can help people who have undergone an 'ablation' procedure for an irregular heartbeat called atrial fibrillation. The main aim is to see if this hydrogen gas therapy can prevent the irregular heartbeat from returning shortly after the ablation (within three months). Researchers will also look at whether participants' quality of life improves significantly during this period. The study is comparing people who receive the hydrogen gas with those who don't, to understand its effects better. They will also track if people need to go to the hospital less often and check inflammation levels in the blood. This is a Phase II trial, meaning it's an early study to see if the treatment is safe and shows promise.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

136

Start

25 Feb 2026

atrial fibrillation

What is this study about?

This study is looking into a new treatment for people who have an irregular heartbeat called atrial fibrillation. If you have atrial fibrillation, your heart beats too fast, too slow, or in an uneven way. One common treatment is a procedure called 'ablation,' which helps to correct these irregular signals in the heart. Sometimes, however, the irregular heartbeat can come back shortly after the ablation.

This research is for people who are having an ablation. The study wants to find out if breathing in a special gas, which contains a small amount of hydrogen mixed with nitrogen, can help prevent the irregular heartbeat from returning in the first three months after the ablation. They also want to see if this hydrogen gas therapy can make a noticeable difference to people's quality of life during this time.

To do this, some people will breathe the hydrogen gas, and others won't. The researchers will then compare the two groups to see if the hydrogen therapy helps. They will also look at how many people need to go back to the hospital or have further treatments for their heartbeat. This is an early stage of research, like a test run, to see if this treatment is effective and safe enough for bigger studies.

Key takeaways

The study tests hydrogen gas therapy for irregular heartbeats after an ablation.
It aims to prevent the return of the irregular heartbeat and improve quality of life.
Participants will either breathe hydrogen gas or not, decided by chance.
The main follow-up period is for the first three months after ablation.
This is an early-stage research study (Phase II) to check effectiveness and safety.

Who may be eligible?

This study is open to both men and women aged 18 years and older.

To be included, you would need to be scheduled for an ablation procedure for atrial fibrillation. The study will likely involve other specific health checks to ensure it's safe for you to participate, but these details are not fully provided here.

If you are interested, it's best to discuss this with your doctor to see if you meet all the requirements for this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled to have an ablation procedure for atrial fibrillation?
Are you a man or a woman?
Are you able to attend regular follow-up appointments after your ablation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two groups: one group will breathe a special gas containing hydrogen, and the other will not. This is decided by chance, like flipping a coin. The hydrogen gas would be given through inhalation, meaning you would breathe it in.

The main focus of the study's measurements will be in the first three months after your ablation procedure. Researchers will regularly check if your irregular heartbeat has returned and will ask you questions about your quality of life using a special questionnaire. They will also take blood samples to check for signs of inflammation. You will have follow-up appointments to track your progress and to see if you've needed any hospital visits or extra treatments for your heart. The study will also ask you and your healthcare team about your experiences with the hydrogen therapy, if you were in that group.

Potential risks and benefits

Participating in a study like this might have potential benefits if the hydrogen gas therapy proves effective in preventing the return of your irregular heartbeat and improving your quality of life. However, as this is an early-stage study, the benefits are not guaranteed. There might also be some potential risks or side effects from breathing the hydrogen gas, which would be carefully monitored by the study team. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common type of irregular heartbeat where the upper chambers of your heart beat very fast and irregularly.

What is an 'ablation' procedure?

Ablation is a procedure that uses heat or cold energy to create tiny scars in your heart tissue, which helps block abnormal electrical signals causing the irregular heartbeat.

What is meant by 'early recurrence'?

Early recurrence means that your irregular heartbeat (atrial fibrillation or similar conditions) returns within the first three months after your ablation procedure.

What does 'quality of life' mean in this study?

In this study, 'quality of life' refers to how your atrial fibrillation affects your daily life, feelings, and activities. It's measured using a specific questionnaire called AFEQT.

Is breathing hydrogen gas safe?

The safety of this particular hydrogen gas therapy is one of the things being carefully looked at in this early-stage study. Researchers will monitor you closely for any potential side effects.