Status:
RECRUITING
POLARx Post Approval Study (POLARx PAS)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 u...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06170606
Start Date
June 28 2024
End Date
May 1 2029
Last Update
December 24 2025
Active Locations (11)
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1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
3
Pima Heart & Vascular Clinical Research
Tucson, Arizona, United States, 85718
4
Torrance Memorial Medical Center
Torrance, California, United States, 90505