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POLARx Post Approval Study (POLARx PAS)
POLARx Post Approval Study (POLARx PAS)

NCT06170606

CompletedNA

Sponsor: Boston Scientific Corporation

Conditions: Paroxysmal Atrial Fibrillation

Interventions: Boston Scientific Cardiac Cryoablation System

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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);
Locations (11)
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Torrance, California, United States
  • Brighton, Colorado, United States
  • Glenwood Springs, Colorado, United States
  • Tampa, Florida, United States
  • Cincinnati, Ohio, United States
  • Columbia, South Carolina, United States
  • Galveston, Texas, United States
  • Grafton, Wisconsin, United States