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

Recruiting now

Conditions studied: Atrial Fibrillation, Paroxysmal or Persistent, Mitral Valve Disease

In brief

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.

Key facts

Study ID

NCT06557616

Run by

Medinice S.A.

People needed

20

Starts

2024-07-03

Expected to finish

2026-06-30

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).
• significant calcification of the left atrium.
• Condition after previous cardiac surgery.
• significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection).
• the patient is currently a participant in another clinical trial.
• The patient is on active biological therapy.
• emergency surgery.
• Life expectancy <12 months.
• Any circumstances that, in the opinion of the Investigator, may prevent the patient from participating in the study, limit the ability to perform the procedures outlined in the study protocol or place an unreasonable risk on the patient.

Where it is running

• Antoni Jurasz University Hospital No. 1 — Bydgoszcz, Poland (enrolling)
• Silesian Centre for Heart Diseases — Zabrze, Poland (enrolling)

Full record on ClinicalTrials.gov

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