POLARx Cardiac Cryoablation System Study

Atrial Fibrillation Clinical Trial

— POLAR ICE  

Official title:

POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250714
• Other study ID #: PY003
• Status: Completed
• Start date: August 6, 2020
• Est. completion date: September 26, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Boston Scientific Cardiac Cryoablation System
cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels
Croatia	Klinicki Bolnicki Centar	Split
France	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
Germany	Herz-und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Staedtisches Klinikum Karlsruhe	Karlsruhe
Germany	Universitaetsklinikum Schleswig-Holstein	Lübeck
Italy	Maria Cecilia Hospital SPA	Cotignola
Italy	Centro Cardiologico Monzino	Milano
Italy	Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina	Roma
Netherlands	Erasmus MC	Rotterdam
Netherlands	Isala Klinieken	Zwolle
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Freeman Hospital	Newcastle-upon-Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Event Free Rate	Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis	12 months
Primary	Failure Free Rate	includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure	12 months
Secondary	Documentation and Rate of Acute Procedural Success	Electrical isolation of a pulmonary vein (PV) is demonstrated at minimum by entrance block using the Cryo Mapping Catheter. The Secondary Effectiveness Endpoint is analyzed using data from all TREATMENT subjects.	Index Procedure