Trial Outcomes & Findings for POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART) (NCT NCT05282823)
NCT ID: NCT05282823
Last Updated: 2025-12-02
Results Overview
Freedom from procedure and device-related adverse events post-index procedure
Recruitment status
COMPLETED
Target enrollment
295 participants
Primary outcome timeframe
12 months
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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295
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Overall Study
COMPLETED
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276
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Overall Study
NOT COMPLETED
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19
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Withdrawal by Subject
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7
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Overall Study
Adverse Event
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1
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Overall Study
did not meet protocol criteria
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Subjects
n=293 Participants
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.
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Age, Continuous
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65 years
STANDARD_DEVIATION 12 • n=293 Participants
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Sex: Female, Male
Female
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100 Participants
n=293 Participants
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Sex: Female, Male
Male
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193 Participants
n=293 Participants
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Region of Enrollment
South Korea
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40 participants
n=293 Participants
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Region of Enrollment
Japan
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253 participants
n=293 Participants
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PRIMARY outcome
Timeframe: 12 monthsFreedom from procedure and device-related adverse events post-index procedure
Outcome measures
| Measure |
Treatment Subjects
n=293 Participants
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.
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|---|---|
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Safety Event Free Rate
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285 Participants
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PRIMARY outcome
Timeframe: 12 monthsFailure 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
Outcome measures
| Measure |
Treatment Subjects
n=293 Participants
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.
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Failure Free Rate
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222 Participants
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SECONDARY outcome
Timeframe: 6 monthFailure 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
Outcome measures
| Measure |
Treatment Subjects
n=293 Participants
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.
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|---|---|
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Failure Free Rate
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236 Participants
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Adverse Events
Treatment Subjects
Serious events: 25 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Subjects
n=293 participants at risk
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.
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Injury, poisoning and procedural complications
Myocardial Perforation with Tamponade
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Procedure related Genitourinary/Renal
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Musculoskeletal and connective tissue disorders
Musculoskeletal
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
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0.68%
2/293 • Number of events 3 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Nervous system disorders
Neurological
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1.0%
3/293 • Number of events 3 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Renal and urinary disorders
Genitourinary
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Respiratory, thoracic and mediastinal disorders
Pulmonary
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Vascular disorders
Coronary Artery Disease
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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General disorders
Syncope
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0.34%
1/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Fistula (arterial/venous)
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Gastroparesis
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0.68%
2/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
AV Block (Transient)
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
Atrial Fibrillation (AF)
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1.7%
5/293 • Number of events 5 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
Atrial Flutter
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0.34%
1/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
Cardiogenic Shock
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
Multiple Heart Failure Symptoms
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
Patient Condition - Cardiovascular - OTHER
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Cardiac disorders
Sinus Bradycardia
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0.68%
2/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Endocrine disorders
Endocrine
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Gastrointestinal disorders
Gastrointestinal
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1.0%
3/293 • Number of events 3 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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General disorders
Adverse Reaction - Allergic Reaction
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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General disorders
Chest Pain - Other
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Other adverse events
| Measure |
Treatment Subjects
n=293 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
EP/Ablation Procedure - Other
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1.7%
5/293 • Number of events 5 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Esophagitis
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Fistula (arterial/venous)
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Gastroparesis
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Hematoma
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Pain cardiovascular (non-ischemic)
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Palpitations
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Phrenic Nerve Injury Permanent
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0.68%
2/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Phrenic Nerve Injury Temporary
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3.8%
11/293 • Number of events 11 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Procedure related Gastrointestinal
|
0.68%
2/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Procedure related Genitourinary/Renal
|
0.68%
2/293 • Number of events 2 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Injury, poisoning and procedural complications
Procedure related Pulmonary (including cough, hemoptysis)
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Nervous system disorders
Neurological
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0.34%
1/293 • Number of events 1 • Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place