Paroxysmal Atrial Fibrillation
Conditions
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).
Interventions
is indicated for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of AF as per current and future guidelines and system IFU/ Tenpubunsyo.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Event Free Rate | 12 months | Freedom from procedure and device-related adverse events post-index procedure |
| Failure Free Rate | 12 months | Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 12-Month, or any interventions for AF/AFL/AT between Days 91 and 12-Month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure Free Rate | 6 month | Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 6-Month, or any interventions for AF/AFL/AT between Days 91 and 6-Month |
Countries
Japan, South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects Subjects will be clinically indicated for pulmonary vein isolation ablation procedure (in compliance with instructions for use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment of paroxysmal AF.
Boston Scientific Cardiac Cryoablation System: is indicated for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of AF as per current and future guidelines and system IFU/ Tenpubunsyo. | 293 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | did not meet protocol criteria | 2 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Treatment Subjects | — |
|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 253 participants | — |
| Region of Enrollment South Korea | 40 participants | — |
| Sex: Female, Male Female | 100 Participants | — |
| Sex: Female, Male Male | 193 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 293 |
| other Total, other adverse events | 30 / 293 |
| serious Total, serious adverse events | 25 / 293 |
Outcome results
Primary
Failure Free Rate
Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 12-Month, or any interventions for AF/AFL/AT between Days 91 and 12-Month
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Subjects | Failure Free Rate | 222 Participants |
Primary
Safety Event Free Rate
Freedom from procedure and device-related adverse events post-index procedure
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Subjects | Safety Event Free Rate | 285 Participants |
Secondary
Failure Free Rate
Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 6-Month, or any interventions for AF/AFL/AT between Days 91 and 6-Month
Time frame: 6 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Subjects | Failure Free Rate | 236 Participants |