RecruitingNCT06557616

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

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


Sponsor

Medinice S.A.

Enrollment

20 participants

Start Date

Jul 3, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device called the CoolCryo System for cardiac cryoablation — a procedure that uses extreme cold to destroy abnormal heart tissue — in patients who have atrial fibrillation and also need mitral valve surgery. The goal is to treat both problems at the same time. **You may be eligible if...** - You are 18 or older and have been scheduled for mitral valve surgery (valve repair or replacement) - You have also been diagnosed with atrial fibrillation (irregular heartbeat) for at least 3 months before surgery - You have signed informed consent **You may NOT be eligible if...** - You have thyroid problems, active infection, or certain electrolyte imbalances that could be causing the atrial fibrillation - You have had prior heart surgery - Your left atrium (a heart chamber) is very enlarged - You are pregnant, breastfeeding, or planning pregnancy within 6 months - You are currently on biological therapy or have less than 12 months life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Antoni Jurasz University Hospital No. 1

Bydgoszcz, Poland

Silesian Centre for Heart Diseases

Zabrze, Poland

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NCT06557616


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