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POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)

NCT05282823 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 295

Last updated 2025-12-02

Study results available
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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)

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Junichi Nitta · Sakakibara Heart Institute

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-26
Primary Completion
2024-10-29
Completion
2024-10-29

Countries

  • Japan
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282823 on ClinicalTrials.gov