RecruitingNot ApplicableNCT06170606

POLARx Post Approval Study (POLARx PAS)

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


Sponsor

Boston Scientific Corporation

Enrollment

200 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-approval study is following patients who receive the POLARx cryoablation system (a device that uses extreme cold to destroy abnormal heart tissue) as treatment for paroxysmal atrial fibrillation (PAF) — episodes of irregular heartbeat that come and go. **You may be eligible if...** - You have symptomatic paroxysmal atrial fibrillation that keeps coming back despite medication - Your doctor has recommended cryoablation as part of your standard care - You have not had a prior ablation procedure in the left atrium of your heart **You may NOT be eligible if...** - You have had a previous left atrium ablation - You have severe narrowing of your pulmonary veins or pulmonary vein stents - You have severe valve disease or a mechanical or biological heart valve replacement - You have an active systemic infection - Your life expectancy is less than 1 year - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBoston 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

View Full Details on ClinicalTrials.gov

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NCT06170606


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