POLARx Post Approval Study (POLARx PAS)
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: Boston Scientific Cardiac Cryoablation System
- Registration Number
- NCT06170606
- Lead Sponsor
- Boston Scientific Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cryoablation Boston Scientific Cardiac Cryoablation System Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System.
- Primary Outcome Measures
Name Time Method 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 12 Months This measure reports the observed safety event-free rate at 12 Months follow up for all treatment and intent subjects. The safety events are a composite of procedure-related and device-related adverse events. Acute Primary Safety Endpoints include:
* Death
* Myocardial infarction (MI)
* Persistent gastroparesis/injury to vagus nerve
* Transient ischemic attack (TIA)
* Stroke/Cerebrovascular accident (CVA)
* Thromboembolism/ Air embolism
* Cardiac tamponade/perforation
* Pneumothorax
* Serious vascular access complications
* Pulmonary edema/heart failure
* AV block not attributable to medication effect or vasovagal reaction
Chronic Primary Safety events (through 12 Months) include:
* Atrial esophageal fistula
* Pulmonary vein stenosis (≥ 70% reduction of diameter) OR presented by patient's symptoms at 12-Month follow-up and requiring interventionPercentage 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 12 Months This measure reports the observed failure-free rate at 12 Months post index procedure. Failure defined as:
* Failure to achieve acute procedural success in the index procedure
* Any documented recurrent AF episode(s), or new onset of AFL or AT events:
* ≥ 30 seconds in duration from any clinical recording devices considered standard of care at the study center (excluding insertable loop recorders)or
* ≥10-second of continuous AF, AFL or AT documented on any 12-lead ECG between Days 91 and 12-Month follow-up
* Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between days 91 and 12 Month Follow Up:
* Repeat procedure
* Electrical and/or pharmacological cardioversion for AF/AFL/AT
* Prescribed a higher dose of any AAD documented at baseline or a new AAD not documented at baseline.
* Hospitalization for AF/AT/AFL
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Pima Heart & Vascular Clinical Research
🇺🇸Tucson, Arizona, United States
Valley View Hospital
🇺🇸Glenwood Springs, Colorado, United States
St. Joseph's Hospital/BayCare Medical Group
🇺🇸Tampa, Florida, United States
University of Texas Medical Branch - Galveston
🇺🇸Galveston, Texas, United States
Aurora Health
🇺🇸Grafton, Wisconsin, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Pima Heart & Vascular Clinical Research
🇺🇸Tucson, Arizona, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Valley View Hospital
🇺🇸Glenwood Springs, Colorado, United States
St. Joseph's Hospital/BayCare Medical Group
🇺🇸Tampa, Florida, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
University of Texas Medical Branch - Galveston
🇺🇸Galveston, Texas, United States
Aurora Health
🇺🇸Grafton, Wisconsin, United States