RECRUITING

POLARx Post Approval Study (POLARx PAS)

Conditions

Paroxysmal Atrial Fibrillation Cryoablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-06-28

Study Completion:2029-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06170606

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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);

Inclusion Criteria

Exclusion 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);

Contacts and Locations

Study Contact

Susan Hampson

CONTACT

508-728-5165

susan.hampson@bsci.com

Principal Investigator

Wilber W Su, MD,FACC,FHRS

STUDY_CHAIR

Banner- University Medical Group- Heart Center, Phoenix, AZ, USA

Study Locations (Sites)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006

United States

Pima Heart & Vascular Clinical Research

Tucson, Arizona, 85718

United States

Valley View Hospital

Glenwood Springs, Colorado, 81601

United States

St. Joseph's Hospital/BayCare Medical Group

Tampa, Florida, 33607

United States

University of Texas Medical Branch - Galveston

Galveston, Texas, 77555

United States

Aurora Health

Grafton, Wisconsin, 53024

United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28

Study Completion Date2029-05

Study Record Updates

Study Start Date2024-06-28

Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

Cryoablation

Additional Relevant MeSH Terms

Paroxysmal Atrial Fibrillation