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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);

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06170606). StuddyBuddy aggregates publicly available trial information.