POLARx Post Approval Study (POLARx PAS)
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT06170606
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br> - Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the<br> Cryoablation System, per physician's medical judgement, and as per standard of care<br><br> - Subjects who are willing and capable of providing informed consent;<br><br> - Subjects who are willing and capable of participating in all testing associated with<br> this clinical study at an approved clinical investigational center;<br><br>Exclusion Criteria:<br><br> - Any known contraindication to an AF ablation or anticoagulation, including those<br> listed in the IFU as legally approved conditions;<br><br> - Any prior LA ablation;<br><br> - Known or pre-existing severe PV Stenosis;<br><br> - Subjects with severe valvular disease OR with a prosthetic - mechanical or<br> biological - heart valve (not including valve repair and annular rings);<br><br> - Presence of any pulmonary vein stents;<br><br> - Subjects with active systemic infection;<br><br> - Subject is unable or not willing to complete follow-up visits and examination for<br> the duration of the study;- Subjects with life expectancy = 1 year per<br> investigator's medical judgement;<br><br> - Women of childbearing potential who are, or plan to become, pregnant during the time<br> of the study (assessment per investigator's discretion);
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models;Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models
- Secondary Outcome Measures
Name Time Method