Using the CoolCryo System to treat Atrial Fibrillation during Mitral Valve Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the safety and efficacy of the CoolCryo system for cardiac cryoablation in patients undergoing mitral valve surgery. It involves endocardial cryoablation of the left and/or right atrium to eliminate atrial fibrillation, a common complication associated with mitral valve defects. The study will include 16 patients who have been diagnosed with paroxysmal or persistent atrial fibrillation for at least three months prior to surgery. Data will be collected during the procedure and at a six-month follow-up to assess outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Antoni Jurasz University Hospital No. 1
  Bydgoszcz, Poland Recruiting
• Silesian Centre for Heart Diseases
  Zabrze, Poland Recruiting

Study contacts

• Principal investigator: Tomasz Hrapkowicz, MD PhD — Silesian Centre for Heart Diseases
• Study coordinator: Tomasz Hrapkowicz, MD PhD
• Email: t.hrapkowicz@sccs.pl
• Phone: +48-519-136-533

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.