Safety Event Free Rate
Primary
· 12 months
Freedom from procedure and device-related adverse events post-index procedure
| Group | Value | 95% CI |
|---|---|---|
| Treatment Subjects | 285 |
Last reviewed · How we verify
NCT05282823: POLAR SMART
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
Completed
Results posted
Last updated 2 December 2025
What this trial tests
trial testing Boston Scientific Cardiac Cryoablation System in Paroxysmal Atrial Fibrillation in 295 participants. Completed in 29 October 2024.
Timeline
26 August 2022
Primary endpoint
29 October 2024
29 October 2024
29 October 2024
Quick facts
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 295 |
| Start date | 26 August 2022 |
| Primary completion | 29 October 2024 |
| Estimated completion | 29 October 2024 |
| Sites | 19 locations across Japan, South Korea |
Drugs / interventions tested
- Boston Scientific Cardiac Cryoablation System
Conditions studied
- Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
Sponsor
Boston Scientific Corporation — full company profile →
Who can join
19 and older, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Failure Free Rate
Primary
· 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
| Group | Value | 95% CI |
|---|---|---|
| Treatment Subjects | 222 |
Failure Free Rate
Secondary
· 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
| Group | Value | 95% CI |
|---|---|---|
| Treatment Subjects | 236 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Any reportable event, experienced by the study subject after informed consent to 12-month follow-up visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment Subjects
Serious: 25/293 (9%)
Deaths: 0/293
Serious adverse events (22 terms)
| Reaction | System | Treatment Subjects |
|---|---|---|
| Atrial Fibrillation (AF) | Cardiac disorders | — |
| Gastrointestinal | Gastrointestinal disorders | — |
| Neurological | Nervous system disorders | — |
| Sinus Bradycardia | Cardiac disorders | — |
| Gastroparesis | Injury, poisoning and procedural complications | — |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| AV Block (Transient) | Cardiac disorders | — |
| Atrial Flutter | Cardiac disorders | — |
| Cardiogenic Shock | Cardiac disorders | — |
| Multiple Heart Failure Symptoms | Cardiac disorders | — |
| Patient Condition - Cardiovascular - OTHER | Cardiac disorders | — |
| Endocrine | Endocrine disorders | — |
| Adverse Reaction - Allergic Reaction | General disorders | — |
| Chest Pain - Other | General disorders | — |
| Syncope | General disorders | — |
| Fistula (arterial/venous) | Injury, poisoning and procedural complications | — |
| Myocardial Perforation with Tamponade | Injury, poisoning and procedural complications | — |
| Procedure related Genitourinary/Renal | Injury, poisoning and procedural complications | — |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | — |
| Genitourinary | Renal and urinary disorders | — |
| Pulmonary | Respiratory, thoracic and mediastinal disorders | — |
| Coronary Artery Disease | Vascular disorders | — |
Other adverse events (13 terms — click to expand)
| Reaction | System | Treatment Subjects |
|---|---|---|
| Phrenic Nerve Injury Temporary | Injury, poisoning and procedural complications | — |
| EP/Ablation Procedure - Other | Injury, poisoning and procedural complications | — |
| Phrenic Nerve Injury Permanent | Injury, poisoning and procedural complications | — |
| Procedure related Gastrointestinal | Injury, poisoning and procedural complications | — |
| Procedure related Genitourinary/Renal | Injury, poisoning and procedural complications | — |
| Esophagitis | Injury, poisoning and procedural complications | — |
| Fistula (arterial/venous) | Injury, poisoning and procedural complications | — |
| Gastroparesis | Injury, poisoning and procedural complications | — |
| Hematoma | Injury, poisoning and procedural complications | — |
| Pain cardiovascular (non-ischemic) | Injury, poisoning and procedural complications | — |
| Palpitations | Injury, poisoning and procedural complications | — |
| Procedure related Pulmonary (including cough, hemoptysis) | Injury, poisoning and procedural complications | — |
| Neurological | Nervous system disorders | — |
Most-reported serious reactions: Atrial Fibrillation (AF), Gastrointestinal, Neurological, Sinus Bradycardia, Gastroparesis, Cancer, AV Block (Transient), Atrial Flutter.
Data from ClinicalTrials.gov NCT05282823 adverse events section.
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05282823
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Boston Scientific Cardiac Cryoablation System
Trials testing the same drug.
- NCT04250714 — POLARx Cardiac Cryoablation System Study · completed
- NCT04133168 — Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation · NA · completed
Other recruiting trials for Paroxysmal Atrial Fibrillation
Currently open trials in the same condition.
- NCT07535268 — REPRESENT-PF Registry · recruiting
- NCT07344961 — Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB) · recruiting
- NCT07281898 — Burst Stimulation for Paroxysmal Atrial Fibrillation · NA · recruiting
- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT06765356 — Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias · Phase 4 · active not recruiting
Other Boston Scientific Corporation trials
Trials by the same sponsor.
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- NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy · NA · not yet recruiting
- NCT07276815 — OverStitch NXT Endoscopic Suture System · NA · not yet recruiting
- NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure · NA · not yet recruiting
- NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05282823 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05282823.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing