Atrial Fibrillation, Paroxysmal or PersistentCoolCryoNCT06557616
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
An observational study of Atrial Fibrillation, Paroxysmal or Persistent and Mitral Valve Disease, run by Medinice S.A. at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal or Persistent, Mitral Valve Disease
- How many people
- 20 participants
- Where
- 2 sitesPoland
- Study dates
- 3 Jul 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Written consent from the patient to participate in the study.
- age ≥18 years.
- patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement "with" or "without" left atrial appendage closure).
- 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.
Who cannot join
- Lack of written consent from the patient to participate in the study.
- Failure to meet the inclusion criteria.
- Contraindications to the cryoablation procedure.
- Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
- co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).
- significant calcification of the left atrium.
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- Condition after previous cardiac surgery.
- significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection).
- the patient is currently a participant in another clinical trial.
- The patient is on active biological therapy.
- emergency surgery.
- Life expectancy <12 months.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Antoni Jurasz University Hospital No. 1
Bydgoszcz, 85-094
Wojciech Pawliszak, MD PhD, +48-604-175-015, w.pawliszak@cm.umk.pl
- Recruiting
Silesian Centre for Heart Diseases
Zabrze, 41-800
Tomasz Hrapkowicz, MD PhD, +48-519-136-533, t.hrapkowicz@sccs.pl
About this study
Official title: 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
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.
Read the detailed description
An open-label, multi-centre, non-randomised study involving 16 patients, male and female, to evaluate the safety and efficacy of the CoolCryo system.
The procedure with the medical device will be performed on female and males aged ≥18 years, qualified for mitral heart valve surgery with a documented comorbidity of paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery excluding acute conditions.
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.
Data to assess the safety and efficacy of the CoolCryo system are collected at the time of the procedure and during the 6-month follow-up of the patient. In the clinical trial of the CoolCryo system, patient management at the Centre is conducted in accordance with the guidelines and standards of Polish and European medical societies, as well as taking into account the best practices developed at the Centre.
Due to the nature of the study population, 14 patients were taken as the minimum group size for which the CoolCryo device will be used. This size appears sufficient to analyse the safety and efficacy of the medical device used and was chosen for practical reasons and not on the basis of a formal sample size estimate. Given the 6-month follow-up period, the proportion of patients who will be lost to follow-up during the study was assumed to be 10 %. Therefore, 16 patients will be treated.
- Keywords
- cryoablation, cardiac cryoablation, arrhythmia, atrial fibrillation, mitral valve, concomitant ablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Secondary outcomes (3)
The occurrence of serious adverse events during surgery (intraoperatively) or after the procedure until the patient is discharged from the unit (postoperatively).
Recording of all adverse events/serious life-threatening events.
Measured: 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.
Recording of all adverse events/serious life-threatening events.
Measured: 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.
To verify whether sinus rhythm is present in the recordings obtained during 48h Holter ECG monitoring.
Measured: 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start3 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, Paroxysmal or PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medinice S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Hrapkowicz, MD PhD, Principal investigator, Silesian Centre for Heart Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557616
- Sponsor's protocol ID
- BK_CIP-02
- Acronym
- CoolCryo
- Status last verified
- Sep 2025
- First submitted
- 14 Aug 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06557616
- Acronym / sponsor ID
- CoolCryo / BK_CIP-02
- Keywords
- cryoablation, cardiac cryoablation, arrhythmia, atrial fibrillation, mitral valve, concomitant ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medinice S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An open-label, multi-centre, non-randomised study involving 16 patients, male and female, to evaluate the safety and efficacy of the CoolCryo system.
The procedure with the medical device will be performed on female and males aged ≥18 years, qualified for mitral heart valve surgery with a documented comorbidity of paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery excluding acute conditions.
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.
Data to assess the safety and efficacy of the CoolCryo system are collected at the time of the procedure and during the 6-month follow-up of the patient. In the clinical trial of the CoolCryo system, patient management at the Centre is conducted in accordance with the guidelines and standards of Polish and European medical societies, as well as taking into account the best practices developed at the Centre.
Due to the nature of the study population, 14 patients were taken as the minimum group size for which the CoolCryo device will be used. This size appears sufficient to analyse the safety and efficacy of the medical device used and was chosen for practical reasons and not on the basis of a formal sample size estimate. Given the 6-month follow-up period, the proportion of patients who will be lost to follow-up during the study was assumed to be 10 %. Therefore, 16 patients will be treated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Written consent from the patient to participate in the study.
- age ≥18 years.
- patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement "with" or "without" left atrial appendage closure).
- 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.
Key exclusion criteria (13 listed)
- Lack of written consent from the patient to participate in the study.
- Failure to meet the inclusion criteria.
- Contraindications to the cryoablation procedure.
- Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
- co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up.
Time frame: 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
To verify whether atrial fibrillation is present in the recordings obtained during 48h Holter. ECG monitorin
Incidence of adverse events and serious adverse events related to the use of the
Time frame: 6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Recording of adverse events/serious life-threatening events.
3 secondary outcomes
The occurrence of serious adverse events during surgery (intraoperatively) or after the procedure until the patient is discharged from the unit (postoperatively).
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomasz Hrapkowicz, MD PhD principal investigator
Silesian Centre for Heart Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, Paroxysmal or Persistent and Mitral Valve Disease, run by Medinice S.A. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Hrapkowicz, MD PhD (+48-519-136-533, t.hrapkowicz@sccs.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up. (time frame: 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.