Paroxysmal Atrial FibrillationPOLAR SMARTNCT05282823
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 19 sites in 2 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Boston Scientific Cardiac Cryoablation System
- Type of treatment
- Medical device
- How many people
- 295 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 26 Aug 2022to 29 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects indicated for the treatment of AF with the cryoablation system;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;
- Subjects who are of legal age to give informed consent specific to the national law.
Who cannot join
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions;
- Any prior LA ablation;
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of cardiac myxoma, LA thrombus or intracardiac mural thrombus;
- 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;
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- Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) within 90 days prior to enrollment;
- 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);
- Any planned ablation in LA except PVI procedure and roof line ablation;
- Any planned ablation in ventricles;
- Subjects undergoing atrial septal defect patch or other surgical procedures at or near the atrial septal defect;
- Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
- Presence of any pulmonary vein stents;
- Subjects with active systemic infection;
- Subjects that have vena cava embolic protection filter devices and/or known femoral thrombus;
- Any previous history of cryoglobulinemia;
- Subjects that are unable to undergo atrium access safely or operate in the atrium as per investigator's medical judgement;
- Subjects with no vascular access or obstruction of the femoral vein;
- Subjects with blood coagulation disorders or diseases;
- Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
- Subjects who are hemodynamically unstable;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);
- Subjects with unrecovered/unresolved Adverse Events from any previous invasive procedure;
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Japan17 sites
Medical Hospital, Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, 113-8519
Chiba University Hospital
Chiba, Chiba, 260-8677
Sakakibara Heart Institute
Fuchu-shi, Tokyo, 183-0003
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, 247-0072
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, 802-8555
Kobe City Medical Center General Hospital
Kobe
Kobe University Hospital
Kobe
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-2102
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Saitama Red Cross Hospital
Saitama, Saitama, 330-8553
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, 564-8565
National Hospital Organization Disaster Medical Center
Tachikawa-shi, Tokyo, 190-0014
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682
Yokosuka Kyosai Hospital
Yokosuka-shi, Kanagawa, 238-8558
South Korea2 sites
Konkuk University Medical Center
Seoul, 05030
Samsung Medical Center
Seoul, 06351
About this study
Official title: 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)
Read the 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).
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Boston Scientific Cardiac Cryoablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Cardiac Cryoablation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Boston Scientific Cardiac Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Event Free Rate
Freedom from procedure and device-related adverse events post-index procedure
Measured: 12 months
Failure Free Rate
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
Measured: 12 months
Secondary outcomes (1)
Failure Free Rate
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start26 Aug 2022
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junichi Nitta, Principal investigator, Sakakibara Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282823
- Sponsor's protocol ID
- PY007
- Acronym
- POLAR SMART
- Status last verified
- Oct 2025
- First submitted
- 8 Mar 2022
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART
- ClinicalTrials.gov ID
- NCT05282823
- Acronym / sponsor ID
- POLAR SMART / PY007
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Subjects | – | Device: Boston Scientific Cardiac Cryoablation SystemSubjects 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Subjects indicated for the treatment of AF with the cryoablation system;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;
- Subjects who are of legal age to give informed consent specific to the national law.
Key exclusion criteria (26 listed)
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions;
- Any prior LA ablation;
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of cardiac myxoma, LA thrombus or intracardiac mural thrombus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston Scientific Cardiac Cryoablation Systemis 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. | Device | Treatment Subjects |
Primary outcome
Safety Event Free Rate
Time frame: 12 months
Freedom from procedure and device-related adverse events post-index procedure
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
1 secondary outcome
Failure Free Rate
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Junichi Nitta principal investigator
Sakakibara Heart Institute
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 19 sites in 2 countries.
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 26 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan, South Korea. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Event Free Rate (time frame: 12 months). 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 2 Dec 2025.