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

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: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Boston Scientific Cardiac Cryoablation 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 Type: Observational
• Enrollment (Actual): 295

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Safety Event Free Rate	Freedom from procedure and device-related adverse events post-index procedure	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 month

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Junichi Nitta, Sakakibara Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): October 29, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID 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