Brief Summary

This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

295

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach

2 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

March 8, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed

5 months until next milestone

Study Start

First participant enrolled

August 26, 2022

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 2, 2025

Completed

Last Updated

December 2, 2025

Status Verified

October 1, 2025

Enrollment Period

2.2 years

First QC Date

March 8, 2022

Results QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

Safety Event Free Rate
Freedom from procedure and device-related adverse events post-index procedure
12 months
Failure Free Rate
Failure to achieve acute procedural success during the procedure, or any documented recurrent AF episode(s), or new onset of atrial flutter (AFL) or any other atrial tachycardia (AT) events between Days 91 and 12-Month, or any interventions for AF/AFL/AT between Days 91 and 12-Month
12 months

Secondary Outcomes (1)

Failure Free Rate
6 month

Study Arms (1)

Treatment Subjects

Subjects will be clinically indicated for pulmonary vein isolation ablation procedure (in compliance with instructions for use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment of paroxysmal AF.

Device: Boston Scientific Cardiac Cryoablation System

Interventions

Boston Scientific Cardiac Cryoablation SystemDEVICE

is indicated for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of AF as per current and future guidelines and system IFU/ Tenpubunsyo.

Treatment Subjects

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects will be clinically indicated for PVI ablation procedure (in compliance with instructions for use (IFU)/Tenpubunsyo as legally approved conditions) for the treatment of paroxysmal AF.

You may qualify if:

Subjects indicated for the treatment of AF with the cryoablation system;
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;
Subjects who are of legal age to give informed consent specific to the national law.

You may not qualify if:

Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions;
Any prior LA ablation;
AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
Known or pre-existing severe Pulmonary Vein Stenosis;
Evidence of cardiac myxoma, LA thrombus or intracardiac mural thrombus;
Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, PCI, ventricular fistula or atrial incision) and any surgery within 90 days prior to enrollment;
Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) within 90 days prior to enrollment;
Any planned OR scheduled cardiac device procedure (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) during and post PVI ablation (during and post-index procedure);
Any planned ablation in LA except PVI procedure and roof line ablation;
Any planned ablation in ventricles;
Subjects undergoing atrial septal defect patch or other surgical procedures at or near the atrial septal defect;
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;
Subjects that have vena cava embolic protection filter devices and/or known femoral thrombus;
+11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boston Scientific Corporationlead

Study Sites (19)

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Hirosaki University Hospital

Hirosaki-shi, Aomori, 036-8563, Japan

Location

Chiba University Hospital

Chiba, Chiba, 260-8677, Japan

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8555, Japan

Location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, 247-0072, Japan

Location

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 231-8682, Japan

Location

Yokosuka Kyosai Hospital

Yokosuka-shi, Kanagawa, 238-8558, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, 880-2102, Japan

Location

National Cerebral and Cardiovascular Center Hospital

Suita-shi, Osaka, 564-8565, Japan

Location

Saitama Red Cross Hospital

Saitama, Saitama, 330-8553, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Medical Hospital, Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Sakakibara Heart Institute

Fuchu-shi, Tokyo, 183-0003, Japan

Location

National Hospital Organization Disaster Medical Center

Tachikawa-shi, Tokyo, 190-0014, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Japan

Location

Kobe University Hospital

Kobe, Japan

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Clinical Trial Manager
Organization: Boston Scientific

Study Officials

Junichi Nitta
Sakakibara Heart Institute
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 16, 2022

Study Start

August 26, 2022

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

December 2, 2025

Results First Posted

December 2, 2025

Record last verified: 2025-10

Locations

KR(2)JP(17)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Treatment Subjects

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations