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

NCT06557616 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation, Paroxysmal or Persistent
  • Mitral Valve Disease

Sponsors & Collaborators

  • Medinice S.A.

    lead INDUSTRY

Principal Investigators

  • Tomasz Hrapkowicz, MD PhD · Silesian Centre for Heart Diseases

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557616 on ClinicalTrials.gov