Paroxysmal Atrial FibrillationNCT06170606
POLARx Post Approval Study (POLARx PAS)
A study testing Boston Scientific Cardiac Cryoablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 11 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Boston Scientific Cardiac Cryoablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Jun 2024to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Intermountain Platte Valley Hospital
Brighton, Colorado, 80601
Bethesda North Hospital
Cincinnati, Ohio, 45242
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
University of Texas Medical Branch - Galveston
Galveston, Texas, 77555
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Valley View Hospital
Glenwood Springs, Colorado, 81601
Aurora Health
Grafton, Wisconsin, 53024
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
St. Joseph's Hospital/BayCare Medical Group
Tampa, Florida, 33607
Torrance Memorial Medical Center
Torrance, California, 90505
Pima Heart & Vascular Clinical Research
Tucson, Arizona, 85718
About this study
Official title: Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation
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).
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Boston Scientific Cardiac Cryoablation System
- Keywords
- Cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Cardiac Cryoablation SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System. Receives: Device: Boston Scientific Cardiac Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 intervention
Measured: 12 Months
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
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start28 Jun 2024
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single arm study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilber W Su, MD,FACC,FHRS, Study chair, Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170606
- Sponsor's protocol ID
- PY008
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06170606
- Acronym / sponsor ID
- PY008
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single arm study
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: Boston Scientific Cardiac Cryoablation SystemSubjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston Scientific Cardiac Cryoablation SystemThe 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 | Device | Cryoablation |
Primary outcome
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
Time frame: 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 intervention
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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilber W Su, MD,FACC,FHRS study chair
Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific Cardiac Cryoablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.