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

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

This study is testing whether the CoolCryo system can safely help people with atrial fibrillation feel better during mitral valve surgery.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medinice S.A. (Industry-sponsored)
• Locations: 2 sites (Bydgoszcz and 1 other locations)
• Trial ID: NCT06557616 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for mitral valve surgery and have a documented history of atrial fibrillation.

Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to the cryoablation procedure will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of atrial fibrillation and its associated risks in patients undergoing mitral valve surgery.

How similar studies have performed: While this approach is being evaluated in this specific context, similar cryoablation techniques have shown promise in other studies for treating atrial fibrillation.

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.

Where this trial is running

Bydgoszcz and 1 other locations

• 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

Conditions Atrial Fibrillation, Paroxysmal or Persistent; Mitral Valve Disease; cryoablation; cardiac cryoablation; arrhythmia; atrial fibrillation; mitral valve; concomitant ablation