RECRUITING

POLARx Post Approval Study (POLARx PAS)

Description

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).

Study Overview

Study Details

Study overview

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).

Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation

POLARx Post Approval Study (POLARx PAS)

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Phoenix

Banner University Medical Center Phoenix, Phoenix, Arizona, United States, 85006

Tucson

Pima Heart & Vascular Clinical Research, Tucson, Arizona, United States, 85718

Glenwood Springs

Valley View Hospital, Glenwood Springs, Colorado, United States, 81601

Tampa

St. Joseph's Hospital/BayCare Medical Group, Tampa, Florida, United States, 33607

Galveston

University of Texas Medical Branch - Galveston, Galveston, Texas, United States, 77555

Grafton

Aurora Health, Grafton, Wisconsin, United States, 53024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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;
  • * 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);

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Wilber W Su, MD,FACC,FHRS, STUDY_CHAIR, Banner- University Medical Group- Heart Center, Phoenix, AZ, USA

Study Record Dates

2029-05