At a glance
ClinicalIndex Comparison RecordN/ACompleted· 295 enrolled
Drug / intervention
Boston Scientific Cardiac Cryoablation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART
In Brief
An observational study evaluating Boston Scientific Cardiac Cryoablation System for Paroxysmal Atrial Fibrillation. Completed, enrolled 295 participants across 19 sites in 2 countries.
Detailed 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)
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesJapan, South Korea
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartAug 2022
Primary CompletionOct 2024
TodayJul 2026
First PostedMar 16, 2022
Enrollment StartAug 26, 2022
Primary CompletionOct 29, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.3 years ago
Interventions
Boston Scientific Cardiac Cryoablation Systemdevice
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.