POLARx Post Approval Study (POLARx PAS)

Purpose

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).

Condition

  • Paroxysmal Atrial Fibrillation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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);

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
prospective, single arm study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cryoablation 		Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System.
  • Device: Boston Scientific Cardiac Cryoablation System
    The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: - POLARx™ or POLARx™ FIT Cryoablation Catheter - POLARMAP™ Catheter - POLARSHEATH™ - SMARTFREEZE™ Console - Diaphragm Movement Sensor (DMS) - Related Accessories

Recruiting Locations

University of Texas Medical Branch - Galveston
Galveston, Texas 77555
Contact:
Lindsey Allen
409-266-7678
listurm@utmb.edu

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Susan Hampson
508-728-5165
susan.hampson@bsci.com