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RECRUITING
NCT06170606
NA

POLARx Post Approval Study (POLARx PAS)

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).

Official title: Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-06-28

Completion Date

2029-05

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DEVICE

Boston Scientific Cardiac Cryoablation System

The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx™ FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories

Locations (11)

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Pima Heart & Vascular Clinical Research

Tucson, Arizona, United States

Torrance Memorial Medical Center

Torrance, California, United States

Intermountain Platte Valley Hospital

Brighton, Colorado, United States

Valley View Hospital

Glenwood Springs, Colorado, United States

St. Joseph's Hospital/BayCare Medical Group

Tampa, Florida, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

Prisma Health Richland Hospital

Columbia, South Carolina, United States

University of Texas Medical Branch - Galveston

Galveston, Texas, United States

Aurora Health

Grafton, Wisconsin, United States