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

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Boston Scientific Cardiac Cryoablation System

• Registration Number: NCT05282823
• Lead Sponsor: Boston Scientific Corporation

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).

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-16
• Study Start: 2022-08-26
• Primary Completion: 2024-10-29
• Study Completion: 2024-10-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Subjects	Boston Scientific Cardiac Cryoablation System	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.

Primary Outcome Measures

Name	Time	Method
Safety event free rate	12 months	Freedom from procedure and device-related adverse events post-index procedure
Failure free rate	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

Secondary Outcome Measures

Name	Time	Method
Failure free rate	6 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 6-Month, or any interventions for AF/AFL/AT between Days 91 and 6-Month

Trial Locations

Locations (19)

Yokosuka Kyosai Hospital; 🇯🇵 Yokosuka-shi, Kanagawa, Japan

Saitama Red Cross Hospital; 🇯🇵 Saitama, Japan

Kobe University Hospital; 🇯🇵 Kobe-shi, Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Hirosaki University Hospital; 🇯🇵 Hirosaki-shi, Aomori, Japan

Chiba University Hospital; 🇯🇵 Chiba-shi, Chiba-ken, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Shonan Kamakura General Hospital; 🇯🇵 Kamakura-shi, Kanagawa, Japan

Yokohama City Minato Red Cross Hospital; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Kyoto University Hospital; 🇯🇵 Kyoto-shi, Kyoto-fu, Japan

Miyazaki Medical Association Hospital; 🇯🇵 Miyazaki-shi, Miyazaki, Japan

National Cerebral and Cardiovascular Center Hospital; 🇯🇵 Suita-shi, Osaka, Japan

Hamamatsu University Hospital; 🇯🇵 Hamamatsu-shi, Shizuoka-ken, 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-shi, Japan

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of