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

NCT ID: NCT05282823

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 295 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2024-10-29

Brief 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)

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Boston Scientific Cardiac Cryoablation System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junichi Nitta

Role: PRINCIPAL_INVESTIGATOR

Sakakibara Heart Institute

Locations

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Chiba University Hospital

Chiba, Chiba, Japan

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, Japan

Yokosuka Kyosai Hospital

Yokosuka-shi, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

National Cerebral and Cardiovascular Center Hospital

Suita-shi, Osaka, Japan

Saitama Red Cross Hospital

Saitama, Saitama, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Medical Hospital, Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, Japan

Sakakibara Heart Institute

Fuchu-shi, Tokyo, Japan

National Hospital Organization Disaster Medical Center

Tachikawa-shi, Tokyo, Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

Kobe University Hospital

Kobe, , Japan

Konkuk University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

Japan; South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PY007

Identifier Type: -

Identifier Source: org_study_id