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POLARx Cardiac Cryoablation System Study (POLAR ICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250714
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment
Atrial Fibrillation 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Safety event free rate [ Time Frame: 12 months ]
    freedom from procedure or device related adverse events after intervention

  2. failure free rate [ Time Frame: 12 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250714


Contacts
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Contact: Nele Cielen, MD +32 2 416 76 33 Nele.cielen@bsci.com

Locations
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Belgium
UZ Brussel Recruiting
Brussels, Belgium
Contact: Carlo de Asmundis, MD         
Germany
Universitaetsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany
Contact: Roland Tilz, MD         
Italy
Maria Cecilia Hospital SPA Recruiting
Cotignola, Italy
Contact: Saverio Iacopino, MD         
Sponsors and Collaborators
Boston Scientific Corporation
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04250714    
Other Study ID Numbers: PY003
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes