Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation

Recruiting Observational Study
Atrial Fibrillation, Paroxysmal or Persistent Mitral Valve Disease
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
20 (estimated)
Sponsor
Medinice S.A. · Industry
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About This 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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Written consent from the patient to participate in the study. 2. age ≥18 years. 3. patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement "with" or "without" left atrial appendage closure). 4. a documented diagnosis of co-occurrence of …
Contacts

Tomasz Hrapkowicz, MD PhD

+48-519-136-533

t.hrapkowicz@sccs.pl

CONTACT