POLARx Cardiac Cryoablation System Study (POLAR ICE)

POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Boston Scientific Cardiac Cryoablation System

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • UZ Brussel
• Croatia
  • Split, Croatia
    • Klinicki Bolnicki Centar
• France
  • Brest, France
    • CHU de Brest - Hôpital de la Cavale Blanche
  • Caen, France
    • CHU de Caen
  • Grenoble, France
    • CHU Grenoble - Hopital Michallon
  • Toulouse, France
    • Clinique Pasteur
  • Tours, France
    • CHRU Hospital Trousseau
• Germany
  • Bad Oeynhausen, Germany
    • Herz-und Diabeteszentrum Nordrhein-Westfalen
  • Berlin, Germany
    • Vivantes Klinikum Am Urban
  • Karlsruhe, Germany
    • Staedtisches Klinikum Karlsruhe
  • Lübeck, Germany
    • Universitaetsklinikum Schleswig-Holstein
• Italy
  • Cotignola, Italy
    • Maria Cecilia Hospital SPA
  • Milano, Italy
    • Centro Cardiologico Monzino
  • Roma, Italy
    • Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC
  • Zwolle, Netherlands
    • Isala Klinieken
• United Kingdom
  • Cambridge, United Kingdom
    • Papworth Hospital
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
  • Newcastle-upon-Tyne, United Kingdom
    • Freeman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

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 patients; Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use	Device: Boston Scientific Cardiac Cryoablation System; cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PY003

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.: Yes