Actively Recruiting
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Led by Medinice S.A. · Updated on 2025-09-23
20
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent from the patient to participate in the study.
- Age 18 years or older.
- Patient qualified for mitral valve surgery (mitral valve plication or replacement with or without left atrial appendage closure).
- Documented diagnosis of paroxysmal or persistent atrial fibrillation for at least 3 months prior to surgery, excluding acute conditions.
You will not qualify if you...
- Lack of written consent to participate in the study.
- Failure to meet inclusion criteria.
- Contraindications to cryoablation.
- Breastfeeding, pregnant, or planning pregnancy within 6 months of treatment.
- Co-morbidities that may cause atrial fibrillation (uncompensated thyroid disorders, acute infection, pheochromocytoma, significant dyselectrolitemia).
- Significant calcification of the left atrium.
- Previous cardiac surgery.
- Significant left atrial enlargement (greater than 10 cm on echocardiography).
- Participation in another clinical trial.
- On active biological therapy.
- Emergency surgery.
- Life expectancy less than 12 months.
- Any condition that may prevent participation, limit study procedures, or pose unreasonable risk according to the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Antoni Jurasz University Hospital No. 1
Bydgoszcz, Poland, 85-094
Actively Recruiting
2
Silesian Centre for Heart Diseases
Zabrze, Poland, 41-800
Actively Recruiting
Research Team
T
Tomasz Hrapkowicz, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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