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Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Sponsor: Medinice S.A.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2024-07-03
Completion Date
2026-06-30
Last Updated
2025-09-23
Healthy Volunteers
No
Locations (2)
Antoni Jurasz University Hospital No. 1
Bydgoszcz, Poland
Silesian Centre for Heart Diseases
Zabrze, Poland