Clinical trial NCT04250714: POLARx Cardiac Cryoablation System Study
Official title: POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients indicated for the treatment of AF with isolation of pulmonary veins technique according to current and future Guidelines and system indications for use

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.

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.

Primary outcomes:
measure: Safety Event Free Rate
timeFrame: 12 months
measure: Failure Free Rate
timeFrame: 12 months
Secondary outcomes:
measure: Documentation and Rate of Acute Procedural Success
timeFrame: Index Procedure
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar
city: Brest
country: France
facility: CHU De Brest - Hopital de la Cavale Blanche
city: Caen
country: France
facility: CHU De Caen
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU Hospital Trousseau
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital SPA
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Roma
country: Italy
facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
References:
citation: 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.
citation: 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.