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Completed
NCT06170606
POLARx Post Approval Study (POLARx PAS)
Conditions: Paroxysmal Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Boston Scientific Corporation
Location: Mercy Gilbert Medical Center Gilbert Arizona
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 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);
Source: ClinicalTrials.gov (NCT06170606). StuddyBuddy aggregates publicly available trial information.