Clinical trial NCT06170606: POLARx Post Approval Study (POLARx PAS)
Official title: Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Cryoablation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single arm study
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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);

Primary outcomes:
measure: Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models
timeFrame: 12 Months
measure: Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Tucson
country: United States
facility: Pima Heart & Vascular Clinical Research
state: Arizona
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Brighton
country: United States
facility: Intermountain Platte Valley Hospital
state: Colorado
city: Glenwood Springs
country: United States
facility: Valley View Hospital
state: Colorado
city: Tampa
country: United States
facility: St. Joseph's Hospital/BayCare Medical Group
state: Florida
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Columbia
country: United States
facility: Prisma Health Richland Hospital
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch - Galveston
state: Texas
city: Grafton
country: United States
facility: Aurora Health
state: Wisconsin
Study officials:
affiliation: Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
name: Wilber W Su, MD,FACC,FHRS
role: STUDY_CHAIR
References: