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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Study Pending
Application Number /
Requirement Number
P220032 / PAS001
Date Original Protocol Accepted 11/17/2023
Date Current Protocol Accepted  
Study Name POLARx PAS
Device Name POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study is a Prospective Multi-site safety and efficacy study of the Boston Scientific Cardiac Cryoablation System for drug refractory, recurrent Paroxysmal atrial fibrillation. The objective of the study is 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 Population Patients being treated for paroxysmal atrial fibrillation (PAF). The study will include a diverse (i.e, race, ethnicity, gender) patient population.
Sample Size Number of subjects: A minimum of 200 de novo treatment subjects with at least 50 US subjects participating in a LUX-Dx Sub-study.
Number of sites: Up to 50 centers globally
Sites location: At least 50% of study sites will be in the United States.
Key Study Endpoints The primary safety endpoint at 12 months is defined as the safety event free rate at 12 months post-procedure. Primary safety events at 12 months will consist of a composite of the following procedure-related and/or device-related adverse events.
Acute primary safety endpoint events, events occurring up to 7 days post-index procedure or hospital discharge, whichever is later, 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 endpoint events, events occurring through 12 months post-index procedure, include:
• Atrial esophageal fistula
• Pulmonary vein stenosis (greater than or equal to 70% reduction of diameter) OR presented by patient’s symptoms at 12-Month follow-up and requiring intervention
• Persistent Phrenic nerve injury
The primary effectiveness endpoint will be evaluated by the 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:
o greater than or equal to 30 seconds in duration from any clinical recording devices considered standard of care at the study center (excluding insertable loop recorders)** or
o greater than or equal to 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:
o Repeat procedure
o Electrical and/or pharmacological cardioversion for AF/AFL/AT
o Prescribed a higher dose of any AAD*** documented at baseline or a new AAD not documented at baseline.
o Hospitalization for AF/AT/AFL
*Acute procedural success is defined as isolation of all pulmonary veins or anatomical equivalents achieved with the BSC Cryoablation System at the end of the index procedure and as demonstrated,at minimum, by entrance block (other techniques of assessment are per investigator’s discretion).
** Subjects will be monitored for recurrences/new onset of arrhythmias by means of clinical visits, 12-lead ECG or any clinical recording devices (for example but not limited to, smart watch, 24-hour Holter monitoring, home monitoring systems or implanted devices etc.) that are per standard of care (SOC) used by the hospital/clinic.
Documentation of episodes captured by standard of care monitoring methods must be verified by investigator and filed in medical records. Recurrences documented on implantable loop recorders for the treatment of atrial fibrillation will be collected but will not be counted as primary effectiveness endpoint events.
***AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence.
Follow-up Visits and Length of Follow-up All subjects treated with the Boston Scientific Cardiac Cryoablation System will be followed for 12 months. Subjects with a pre-existing LUX-Dx or a LUX-Dx inserted within 7 days of the ablation procedure will have arrhythmia recurrence monitored remotely via the LATITUDE Home Monitoring System to assess for arrhythmia recurrence for up to 3 years.
Subjects will undergo the index procedure and be followed at pre-discharge, 3 Month, 6 Month and 12 Month visits.
Attempt subjects will receive a phone call at 30 days post-procedure to verify adverse events and complications.
The total study duration is expected to take 5 years.

POLARx PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 02/06/2024 02/06/2024 On Time
1 year report 08/07/2024    
18 month report 02/05/2025    
2 year report 08/07/2025    
3 year report 08/07/2026    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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