POLARx Post Approval Study (POLARx PAS)

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 28, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2029

Conditions
Paroxysmal Atrial Fibrillation
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"

Trial Locations (11)

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

33607

WITHDRAWN

St. Joseph's Hospital/BayCare Medical Group, Tampa

45242

RECRUITING

Bethesda North Hospital, Cincinnati

53024

RECRUITING

Aurora Health, Grafton

77555

RECRUITING

University of Texas Medical Branch - Galveston, Galveston

80601

WITHDRAWN

Intermountain Platte Valley Hospital, Brighton

81601

RECRUITING

Valley View Hospital, Glenwood Springs

85006

RECRUITING

Banner University Medical Center Phoenix, Phoenix

85297

RECRUITING

Mercy Gilbert Medical Center, Gilbert

85718

WITHDRAWN

Pima Heart & Vascular Clinical Research, Tucson

90505

RECRUITING

Torrance Memorial Medical Center, Torrance

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY