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

Paroxysmal Atrial Fibrillation Clinical Trial

— POLAR SMART  

Official title:

POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05282823
• Other study ID #: PY007
• Status: Active, not recruiting
• Start date: August 26, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Japan	Medical Hospital, Tokyo Medical and Dental University	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital	Chiba-shi	Chiba-ken
Japan	Sakakibara Heart Institute	Fuchu-shi	Tokyo
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka-ken
Japan	Hirosaki University Hospital	Hirosaki-shi	Aomori
Japan	Shonan Kamakura General Hospital	Kamakura-shi	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu-shi	Fukuoka
Japan	Kobe City Medical Center General Hospital	Kobe-shi
Japan	Kobe University Hospital	Kobe-shi
Japan	Kyoto University Hospital	Kyoto-shi	Kyoto-fu
Japan	Miyazaki Medical Association Hospital	Miyazaki-shi	Miyazaki
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital	Nagoya-shi	Aichi
Japan	Saitama Red Cross Hospital	Saitama
Japan	National Cerebral and Cardiovascular Center Hospital	Suita-shi	Osaka
Japan	National Hospital Organization Disaster Medical Center	Tachikawa-shi	Tokyo
Japan	Yokohama City Minato Red Cross Hospital	Yokohama-shi	Kanagawa
Japan	Yokosuka Kyosai Hospital	Yokosuka-shi	Kanagawa
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety event free rate	Freedom from procedure and device-related adverse events post-index procedure	12 months
Primary	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	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 months