POLARx Post Approval Study (POLARx PAS)

Boston Scientific

Status

Enrolling

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Boston Scientific Cardiac Cryoablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06170606

PY008

Details and patient eligibility

About

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).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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);