POLARx Post Approval Study (POLARx PAS)

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT06170606

Run by

Boston Scientific Corporation

People needed

200

Starts

2024-06-28

Expected to finish

2026-05-20

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;

You may not qualify if…

• Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
• Any prior LA ablation;
• Known or pre-existing severe PV Stenosis;
• Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
• Presence of any pulmonary vein stents;
• Subjects with active systemic infection;
• Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);

Where it is running

• 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

Full record on ClinicalTrials.gov

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