Tests the CoolCryo system for atrial fibrillation during mitral valve surgery
Tests a cold-based heart procedure for atrial fibrillation in adults having mitral valve surgery.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Key facts
- Where
- Bydgoszcz and Zabrze, PolandSee the 2 sites
Where in Poland
- Antoni Jurasz University Hospital No. 1Bydgoszcz, PolandTaking people
- Silesian Centre for Heart DiseasesZabrze, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medinice S.A.
- Trial code
- NCT06557616
- Record updated
- 23 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Condition after previous cardiac surgery; The patient is on active biological therapy; emergency surgery; 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); 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.