POLARx Post Approval Study (POLARx PAS)

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).

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Gilbert Medical Center, Gilbert, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Boston Scientific Cardiac Cryoablation System

Device

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 14, 2023
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed