Clinical trial NCT05282823: POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
Official title: POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 295
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be clinically indicated for PVI ablation procedure (in compliance with instructions for use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment of paroxysmal AF.

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 isolation (PVI) in the ablation treatment of De Novo Atrial Fibrillation (AF).

Eligibility criteria: Inclusion Criteria:

1. Subjects indicated for the treatment of AF with the cryoablation system;
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 who are of legal age to give informed consent specific to the national law.

Exclusion Criteria:

1. Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions;
2. Any prior LA ablation;
3. AF 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 cardiac myxoma, LA thrombus or intracardiac mural thrombus;
6. 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;
7. Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) within 90 days prior to enrollment;
8. 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);
9. Any planned ablation in LA except PVI procedure and roof line ablation;
10. Any planned ablation in ventricles;
11. Subjects undergoing atrial septal defect patch or other surgical procedures at or near the atrial septal defect;
12. Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
13. Presence of any pulmonary vein stents;
14. Subjects with active systemic infection;
15. Subjects that have vena cava embolic protection filter devices and/or known femoral thrombus;
16. Any previous history of cryoglobulinemia;
17. Subjects that are unable to undergo atrium access safely or operate in the atrium as per investigator's medical judgement;
18. Subjects with no vascular access or obstruction of the femoral vein;
19. Subjects with blood coagulation disorders or diseases;
20. Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
21. Subjects who are hemodynamically unstable;
22. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
23. Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
24. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);
25. Subjects with unrecovered/unresolved Adverse Events from any previous invasive procedure;
26. 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.

Primary outcomes:
measure: Safety event free rate
timeFrame: 12 months
measure: Failure free rate
timeFrame: 12 months
Secondary outcomes:
measure: Failure free rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba-ken
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Yokosuka-shi
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital
state: Kyoto-fu
city: Miyazaki-shi
country: Japan
facility: Miyazaki Medical Association Hospital
state: Miyazaki
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center Hospital
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka-ken
city: Bunkyo-ku
country: Japan
facility: Medical Hospital, Tokyo Medical and Dental University
state: Tokyo
city: Fuchu-shi
country: Japan
facility: Sakakibara Heart Institute
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
city: Saitama
country: Japan
facility: Saitama Red Cross Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Sakakibara Heart Institute
name: Junichi Nitta
role: PRINCIPAL_INVESTIGATOR
References: