NCT06557616Recruiting
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Evaluation of the Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation in a Single-arm, Non-randomised, Open-label Clinical Trial
Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke, heart failure and death.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- Jul 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Medinice S.A.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06557616
What you commit to
- Study type: Observational
- Planned participants: 20
- From Jul 2024 to the primary completion date, Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Condition after previous cardiac surgery.
- The patient is on active biological therapy.
- emergency surgery.
Other illness
- Failure to meet the inclusion criteria.
- co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).
Other
- Lack of written consent from the patient to participate in the study.
- Contraindications to the cryoablation procedure.
- Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
- significant calcification of the left atrium.
- significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection).
- the patient is currently a participant in another clinical trial.
- Life expectancy \<12 months.
- Any circumstances that, in the opinion of the Investigator, may prevent the patient from participating in the study, limit the ability to perform the procedures outlined in the study protocol or place an unreasonable risk on the patient.
Who the study is looking for
- Written consent from the patient to participate in the study.
- age ≥18 years.
- patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement "with" or "without" left atrial appendage closure).
- a documented diagnosis of co-occurrence of paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery with exclusion of acute conditions.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antoni Jurasz University Hospital No. 1 Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Silesian Centre for Heart Diseases Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.