NCT06557616 Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
| NCT ID | NCT06557616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medinice S.A. |
| Condition | Atrial Fibrillation, Paroxysmal or Persistent |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-07-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery with exclusion of acute conditions. Exclusion Criteria: 1. Lack of written consent from the patient to participate in the study. 2. Failure to meet the inclusion criteria. 3. Contraindications to the cryoablation procedure. 4. Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment. 5. co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia). 6. significant calcification of the left atrium. 7. Condition after previous cardiac surgery. 8. significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection). 9. the patient is currently a participant in another clinical trial. 10. The patient is on active biological therapy. 11. emergency surgery. 12. Life expectancy \<12 months. 13. 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.
Contact & Investigator
Tomasz Hrapkowicz, MD PhD
PRINCIPAL INVESTIGATOR
Silesian Centre for Heart Diseases
Frequently Asked Questions
Who can join the NCT06557616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation, Paroxysmal or Persistent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557616 currently recruiting?
Yes, NCT06557616 is actively recruiting participants. Contact the research team at t.hrapkowicz@sccs.pl for enrollment information.
Where is the NCT06557616 trial being conducted?
This trial is being conducted at Bydgoszcz, Poland, Zabrze, Poland.
Who is sponsoring the NCT06557616 clinical trial?
NCT06557616 is sponsored by Medinice S.A.. The principal investigator is Tomasz Hrapkowicz, MD PhD at Silesian Centre for Heart Diseases. The trial plans to enroll 20 participants.
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