POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART) (POLAR SMART)

November 14, 2025 updated by: Boston Scientific Corporation

POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART

This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will collect real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of De Novo Atrial Fibrillation (AF).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Kobe, Japan
        • Kobe City Medical Center General Hospital
      • Kobe, Japan
        • Kobe University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8650
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8563
        • Hirosaki University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8677
        • Chiba University Hospital
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-0072
        • Shonan Kamakura General Hospital
      • Yokohama, Kanagawa, Japan, 231-8682
        • Yokohama city minato Red Cross Hospital
      • Yokosuka-shi, Kanagawa, Japan, 238-8558
        • Yokosuka Kyosai Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 880-2102
        • Miyazaki Medical Association Hospital
    • Osaka
      • Suita-shi, Osaka, Japan, 564-8565
        • National Cerebral and Cardiovascular Center Hospital
    • Saitama
      • Saitama, Saitama, Japan, 330-8553
        • Saitama Red Cross Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Medical Hospital, Tokyo Medical and Dental University
      • Fuchu-shi, Tokyo, Japan, 183-0003
        • Sakakibara Heart Institute
      • Tachikawa-shi, Tokyo, Japan, 190-0014
        • National Hospital Organization Disaster Medical Center
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Treatment Subjects
Subjects will be clinically indicated for pulmonary vein isolation ablation procedure (in compliance with instructions for use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment of paroxysmal AF.
Device: Boston Scientific Cardiac Cryoablation System
is indicated for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of AF as per current and future guidelines and system IFU/ Tenpubunsyo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Event Free Rate
Time Frame: 12 months
Freedom from procedure and device-related adverse events post-index procedure
12 months
Failure Free Rate
Time Frame: 12 months
Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 12-Month, or any interventions for AF/AFL/AT between Days 91 and 12-Month
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Failure Free Rate
Time Frame: 6 month
Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 6-Month, or any interventions for AF/AFL/AT between Days 91 and 6-Month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junichi Nitta, Sakakibara Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PY007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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