University of Texas Medical Branch

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.