Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedinice S.A.
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Lack of written consent from the patient to participate in the study.
Failure to meet the inclusion criteria.
Contraindications to the cryoablation procedure.
Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov