CoolCryo
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
Sponsor study identifier
observational
20
1 country
2
Study Start
July 3, 2024
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2024
Actual (reported)August 14, 2024
Actual (reported)August 16, 2024
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up.
To verify whether atrial fibrillation is present in the recordings obtained during 48h Holter. ECG monitorin
12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Incidence of adverse events and serious adverse events related to the use of the
Recording of adverse events/serious life-threatening events.
6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
The occurrence of serious adverse events during surgery (intraoperatively) or after the procedure until the patient is discharged from the unit (postoperatively).
During the procedure, 6 day (+/- 1 day) after the procedure
Incidence of all adverse events and serious adverse events at 6-month follow-up after surgery.
6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
The proportion of patients who had a return to sinus rhythm at 3 and 6 months postoperatively.
12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Sixteen patients, male and female, aged ≥18 years, qualified for mitral heart valve surgery with documented (in at least one ECG recording) co-occurrence of paroxysmal or persistent atrial fibrillation (AF) will undergo the procedure with the medical device. There is also a prediction of 10 per cent of patients (screen failure) who do not meet the inclusion and/or exclusion criteria after signing informed consent. Additionally, there may be perioperative situations where the cryoablation procedure is not performed due to potential acute aortic dissection or undiagnosed conditions necessitating a change in surgical tactics (e.g. pericarditis). It is estimated that the above situation may affect 1-2 study participants who will be given drop-out status.
Antoni Jurasz University Hospital No. 1
Bydgoszcz, 85-094, Poland
Silesian Centre for Heart Diseases
Zabrze, 41-800, Poland
Tomasz Hrapkowicz, MD PhD
Silesian Centre for Heart Diseases
First Submitted
August 14, 2024
First Posted
August 16, 2024
Study Start
July 3, 2024
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
Contact the study team to confirm eligibility.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 23, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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