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Freezing out AFib: new device tested in Real-World study

NCT ID NCT05282823

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how safe and effective a freezing treatment (cryoablation) is for people with a type of irregular heartbeat called paroxysmal atrial fibrillation (AFib). The treatment uses a device called POLARx to freeze heart tissue and stop the faulty signals causing AFib. 295 patients took part, and researchers tracked any side effects and whether the heartbeat stayed normal for up to a year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

295 people

The number who actually took part.

Started

Aug 2022

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects will be clinically indicated for PVI ablation procedure (in compliance with instructions for use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment of paroxysmal AF.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects indicated for the treatment of AF with the cryoablation system; 2. Subjects who are willing and capable of providing informed consent; 3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center; 4. Subjects who are of legal age to give informed consent specific to the national law. Exclusion Criteria: 1. Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions; 2. Any prior LA ablation; 3. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause; 4. Known or pre-existing severe Pulmonary Vein Stenosis; 5. Evidence of cardiac myxoma, LA thrombus or intracardiac mural thrombus; 6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, PCI, ventricular fistula or atrial incision) and any surgery within 90 days prior to enrollment; 7. Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) within 90 days prior to enrollment; 8. Any planned OR scheduled cardiac device procedure (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) during and post PVI ablation (during and post-index procedure); 9. Any planned ablation in LA except PVI procedure and roof line ablation; 10. Any planned ablation in ventricles; 11. Subjects undergoing atrial septal defect patch or other surgical procedures at or near the atrial septal defect; 12. Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings); 13. Presence of any pulmonary vein stents; 14. Subjects with active systemic infection; 15. Subjects that have vena cava embolic protection filter devices and/or known femoral thrombus; 16. Any previous history of cryoglobulinemia; 17. Subjects that are unable to undergo atrium access safely or operate in the atrium as per investigator's medical judgement; 18. Subjects with no vascular access or obstruction of the femoral vein; 19. Subjects with blood coagulation disorders or diseases; 20. Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment; 21. Subjects who are hemodynamically unstable; 22. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study; 23. Subjects with life expectancy ≤ 1 year per investigator's medical judgement; 24. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion); 25. Subjects with unrecovered/unresolved Adverse Events from any previous invasive procedure; 26. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with POLAR SMART study. Exception when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor for approval.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal atrial fibrillation

Contacts and locations

Locations

  • Chiba University Hospital

    Chiba, Chiba, 260-8677, Japan

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, 036-8563, Japan

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Japan

  • Kobe University Hospital

    Kobe, Japan

  • Kokura Memorial Hospital

    Kitakyushu-shi, Fukuoka, 802-8555, Japan

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Medical Hospital, Tokyo Medical and Dental University

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, 880-2102, Japan

  • National Cerebral and Cardiovascular Center Hospital

    Suita-shi, Osaka, 564-8565, Japan

  • National Hospital Organization Disaster Medical Center

    Tachikawa-shi, Tokyo, 190-0014, Japan

  • Saitama Red Cross Hospital

    Saitama, Saitama, 330-8553, Japan

  • Sakakibara Heart Institute

    Fuchu-shi, Tokyo, 183-0003, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa, 247-0072, Japan

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682, Japan

  • Yokosuka Kyosai Hospital

    Yokosuka-shi, Kanagawa, 238-8558, Japan

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