POLARx Cardiac Cryoablation System Study

NCT ID: NCT04250714

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2022-09-26

Brief Summary

This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

Detailed Description

The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

Treatment patients

Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use

Boston Scientific Cardiac Cryoablation System

Intervention Type: DEVICE

cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins

Interventions

Boston Scientific Cardiac Cryoablation System

cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;

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 whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria

1. Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;

2. Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;

3. Atrial fibrillation 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 myxoma, LA thrombus or intracardiac mural thrombus;

6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment;

7. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment;

8. Implanted Left Atrial Appendage Closure device prior to the index procedure;

9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;

10. Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);

11. Presence of any pulmonary vein stents;

12. Active systemic infection;

13. Vena cava embolic protection filter devices and/ or known femoral thrombus;

14. Any previous history of cryoglobulinemia;

15. History of blood clotting or bleeding disease;

16. Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;

17. Subjects who are hemodynamically unstable;

18. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;

19. Life expectancy ≤ 1 year per investigator's opinion;

20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion);

21. Unrecovered/unresolved Adverse Events from any previous invasive Procedure;

22. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except 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 to determine eligibility.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Brussels, , Belgium

Klinicki Bolnicki Centar

Split, , Croatia

CHU De Brest - Hopital de la Cavale Blanche

Brest, , France

CHU De Caen

Caen, , France

CHU Grenoble - Hopital Michallon

Grenoble, , France

Clinique Pasteur

Toulouse, , France

CHRU Hospital Trousseau

Tours, , France

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, , Germany

Vivantes Klinikum Am Urban

Berlin, , Germany

Staedtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Maria Cecilia Hospital SPA

Cotignola, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

Roma, , Italy

Erasmus MC

Rotterdam, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Papworth Hospital

Cambridge, , United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Countries

Belgium; Croatia; France; Germany; Italy; Netherlands; United Kingdom

References

Luik A, Anic A, Martin CA, Tilz RR, Yap SC, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Defaye P. One-Year Success Rates of a Stable, Low Pressure Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation: Results of the Prospective, International, Multicenter POLAR ICE Study. J Cardiovasc Electrophysiol. 2025 May;36(5):1046-1052. doi: 10.1111/jce.16645. Epub 2025 Mar 19.

Reference Type: BACKGROUND

PMID: 40108686 (View on PubMed)

Martin CA, Tilz RRR, Anic A, Defaye P, Luik A, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Yap SC; POLAR ICE Investigators. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. doi: 10.1111/jce.15861. Epub 2023 Feb 23.

Reference Type: RESULT

PMID: 36786515 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PY003

Identifier Type: -

Identifier Source: org_study_id