Plain-English translation of NCT06557616 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This trial is testing a medical device called the CoolCryo System, which uses freezing technology to treat a type of irregular heartbeat called atrial fibrillation. The device is used during heart valve surgery to try to eliminate the irregular heartbeat at the same time the valve problem is being fixed. Researchers want to see if this approach is safe and effective for patients who need both procedures.
Atrial fibrillation is a common problem that develops in people with heart valve disease, and it increases the risk of stroke, heart failure, and serious complications. This trial exists to find out whether using the CoolCryo System during valve surgery can successfully treat both problems at once and improve patient outcomes.
You likely qualify if…
You likely don't qualify if…
If you qualify, you will undergo heart valve surgery with the CoolCryo System used to treat your irregular heartbeat at the same time. After your surgery, you will have follow-up visits over a 6-month period so doctors can monitor your recovery, check whether the irregular heartbeat has been eliminated, and watch for any side effects or complications. The study will collect information about your health during the procedure and throughout these 6 months of follow-up.
AI-generated summary from trial data · Jul 16, 2026 · Not medical advice
Poland
Sponsor
Medinice S.A.
Enrollment target
~20 participants
Started
July 2024
Primary completion
June 2026
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years and older
Last updated on clinicaltrials.gov in September 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Tomasz Hrapkowicz, MD PhD
Silesian Centre for Heart Diseases
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.