Plain-English translation of NCT06828939 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing a new device called the OptiShot Pulsed Field Ablation Balloon System, which is designed to treat atrial fibrillation (an irregular heartbeat condition). The device is used during a minimally invasive catheter procedure to isolate the pulmonary veins — the blood vessels that feed the heart — which often trigger irregular heartbeats. This is a first-of-its-kind study to see if this new treatment is safe and effective for patients with paroxysmal atrial fibrillation who have either failed or cannot tolerate medication.
Current treatments for atrial fibrillation include medications and traditional ablation procedures, but not all patients respond well to these options. This trial is testing a newer technology that may offer a simpler, safer alternative for treating this common heart rhythm disorder.
You likely qualify if…
You likely don't qualify if…
You will undergo one catheter ablation procedure using the new OptiShot balloon device, performed by a specialist cardiologist at the study site. After the procedure, you will be monitored and will need to attend follow-up visits for one year to assess how well the treatment is working and to check for any side effects. During these visits, you may have heart rhythm checks, imaging tests, and assessments of your symptoms.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
Czechia