Recruiting

Testing a new heart rhythm device for atrial fibrillation treatment

Plain-English translation of NCT05115214 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

Read our Atrial Fibrillation research guide →

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is evaluating the safety and effectiveness of the Affera SpherePVI™ Multi-Ablation System, a catheter-based device designed to treat paroxysmal atrial fibrillation (a condition where your heart's upper chambers beat irregularly). The treatment works by using targeted energy to create small scars in heart tissue that disrupt the abnormal electrical signals causing irregular heartbeats. Researchers want to see how well this new device works and whether it's safe for people whose irregular heartbeats haven't been controlled by medication alone.

Atrial fibrillation can cause serious problems like stroke and heart failure, and many patients don't respond well to antiarrhythmic medications. This trial exists to determine whether this new catheter-based treatment offers a safer and more effective option for people who need more than just pills to manage their condition.

Do you qualify?

You likely qualify if…

you have been diagnosed with paroxysmal or persistent atrial fibrillation documented by a doctor and have had at least two confirmed episodes in the past 12 months
you have tried at least one antiarrhythmic medication that either didn't work or caused unacceptable side effects
you are between 18 and 75 years old
you are considered a suitable candidate for catheter ablation by your cardiologist
you are able and willing to complete all required pre-procedure, post-procedure, and follow-up testing visits

You likely don't qualify if…

you have had atrial fibrillation continuously for more than 12 months (long-standing persistent AF)
you have previously had a catheter ablation, surgical ablation, or certain cardiac procedures in your left atrium
you have had a heart attack, major cardiac surgery, or coronary stent placement within the past 3 months
you have a blood clotting or bleeding disorder, or conditions that prevent you from safely taking blood thinners
you have heart failure that is not well controlled, certain structural heart problems, or a very enlarged left atrium

What participation looks like

If you qualify and enroll, you will undergo the SpherePVI™ catheter ablation procedure, where a thin tube is guided through blood vessels to your heart to treat the irregular rhythm. You will need to attend multiple follow-up visits and testing appointments after the procedure to monitor your heart's rhythm and check for any safety concerns. The study will track approximately 150 participants total across multiple medical centers.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(2 sites)

Czechia

Homolka Hospital, Prague

Institute Klinicke a Experimentalni Mediciny, Prague