Status:
COMPLETED
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
19+ years
Brief Summary
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)
Detailed Description
The study will collect real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System) when used to perform pulmonary vein is...
Eligibility Criteria
Inclusion
- Subjects indicated for the treatment of AF with the cryoablation system;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;
- Subjects who are of legal age to give informed consent specific to the national law.
Exclusion
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions;
- Any prior LA ablation;
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of cardiac myxoma, LA thrombus or intracardiac mural thrombus;
- Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, PCI, ventricular fistula or atrial incision) and any surgery within 90 days prior to enrollment;
- Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) within 90 days prior to enrollment;
- Any planned OR scheduled cardiac device procedure (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) during and post PVI ablation (during and post-index procedure);
- Any planned ablation in LA except PVI procedure and roof line ablation;
- Any planned ablation in ventricles;
- Subjects undergoing atrial septal defect patch or other surgical procedures at or near the atrial septal defect;
- Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
- Presence of any pulmonary vein stents;
- Subjects with active systemic infection;
- Subjects that have vena cava embolic protection filter devices and/or known femoral thrombus;
- Any previous history of cryoglobulinemia;
- Subjects that are unable to undergo atrium access safely or operate in the atrium as per investigator's medical judgement;
- Subjects with no vascular access or obstruction of the femoral vein;
- Subjects with blood coagulation disorders or diseases;
- Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
- Subjects who are hemodynamically unstable;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);
- Subjects with unrecovered/unresolved Adverse Events from any previous invasive procedure;
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with POLAR SMART study. Exception 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 for approval.
Key Trial Info
Start Date :
August 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 29 2024
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT05282823
Start Date
August 26 2022
End Date
October 29 2024
Last Update
December 2 2025
Active Locations (19)
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1
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan, 466-8650
2
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan, 036-8563
3
Chiba University Hospital
Chiba, Chiba, Japan, 260-8677
4
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan, 802-8555