Atrial FibrillationPOLAR ICENCT04250714
POLARx Cardiac Cryoablation System Study
An observational study of Atrial Fibrillation, run by Boston Scientific Corporation at 19 sites in 7 countries.
Trial summary
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Boston Scientific Cardiac Cryoablation System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 6 Aug 2020to 26 Sep 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: patients indicated for the treatment of AF with isolation of pulmonary veins technique according to current and future Guidelines and system indications for use
Who may be able to join
- Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
- 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 whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Who cannot join
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
- Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of myxoma, LA thrombus or intracardiac mural thrombus;
- Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment;
Show all 22Show fewer
- Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment;
- Implanted Left Atrial Appendage Closure device prior to the index procedure;
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;
- 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;
- Active systemic infection;
- Vena cava embolic protection filter devices and/ or known femoral thrombus;
- Any previous history of cryoglobulinemia;
- History of blood clotting or bleeding disease;
- Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
- Subjects who are hemodynamically unstable;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Life expectancy ≤ 1 year per investigator's opinion;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion);
- Unrecovered/unresolved Adverse Events from any previous invasive Procedure;
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
France5 sites
CHU De Brest - Hopital de la Cavale Blanche
Brest
CHU De Caen
Caen
CHU Grenoble - Hopital Michallon
Grenoble
Clinique Pasteur
Toulouse
CHRU Hospital Trousseau
Tours
Germany4 sites
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen
Vivantes Klinikum Am Urban
Berlin
Staedtisches Klinikum Karlsruhe
Karlsruhe
Universitaetsklinikum Schleswig-Holstein
Lübeck
Italy3 sites
Maria Cecilia Hospital SPA
Cotignola
Centro Cardiologico Monzino
Milan
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
Roma
United Kingdom3 sites
Papworth Hospital
Cambridge
Liverpool Heart and Chest Hospital
Liverpool
Freeman Hospital
Newcastle upon Tyne
About this study
Official title: POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
Read the detailed description
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.
- Conditions
- Atrial Fibrillation
- Being tested
- Boston Scientific Cardiac Cryoablation System
- 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
cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
| Study group | Role | What they receive |
|---|---|---|
| Treatment patients | Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use Receives: Device: Boston Scientific Cardiac Cryoablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Event Free Rate
Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis
Measured: 12 months
Failure Free Rate
includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure
Measured: 12 months
Secondary outcomes (1)
Documentation and Rate of Acute Procedural Success
Electrical isolation of a pulmonary vein (PV) is demonstrated at minimum by entrance block using the Cryo Mapping Catheter. The Secondary Effectiveness Endpoint is analyzed using data from all TREATMENT subjects.
Measured: Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start6 Aug 2020
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250714
- Sponsor's protocol ID
- PY003
- Acronym
- POLAR ICE
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2020
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luik A, Anic A, Martin CA, Tilz RR, Yap SC, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Defaye P. One-Year Success Rates of a Stable, Low Pressure Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation: Results of the Prospective, International, Multicenter POLAR ICE Study. J Cardiovasc Electrophysiol. 2025 May;36(5):1046-1052. doi: 10.1111/jce.16645. Epub 2025 Mar 19.
PubMed 40108686Martin CA, Tilz RRR, Anic A, Defaye P, Luik A, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Yap SC; POLAR ICE Investigators. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. doi: 10.1111/jce.15861. Epub 2023 Feb 23.
PubMed 36786515
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04250714
- Acronym / sponsor ID
- POLAR ICE / PY003
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 12 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
Detailed description
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment patients | – | Device: Boston Scientific Cardiac Cryoablation SystemSubjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients indicated for the treatment of AF with isolation of pulmonary veins technique according to current and future Guidelines and system indications for use
Key inclusion criteria (4 listed)
- Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
- 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 whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Key exclusion criteria (22 listed)
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
- Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of myxoma, LA thrombus or intracardiac mural thrombus;
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 Systemcryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins | Device | Treatment patients |
Primary outcome
Safety Event Free Rate
Time frame: 12 months
Freedom from procedure or device related adverse events after intervention, analyzed in all treatment and attempt subjects. The Primary Safety Endpoint is analyzed using data from all TREATMENT and ATTEMPT subjects including those with missing data. Subjects with missing data are censored at the appropriate timepoint in the KM analysis
Failure Free Rate
Time frame: 12 months
includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure
1 secondary outcome
Documentation and Rate of Acute Procedural Success
Time frame: Index Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40108686Luik A, Anic A, Martin CA, Tilz RR, Yap SC, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Defaye P. One-Year Success Rates of a Stable, Low Pressure Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation: Results of the Prospective, International, Multicenter POLAR ICE Study. J Cardiovasc Electrophysiol. 2025 May;36(5):1046-1052. doi: 10.1111/jce.16645. Epub 2025 Mar 19.
- Results publication: PubMed 36786515Martin CA, Tilz RRR, Anic A, Defaye P, Luik A, de Asmundis C, Champ-Rigot L, Iacopino S, Sommer P, Albrecht EM, Raybuck JD, Richards E, Cielen N, Yap SC; POLAR ICE Investigators. Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):833-840. doi: 10.1111/jce.15861. Epub 2023 Feb 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Boston Scientific Corporation at 19 sites in 7 countries.
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 4 inclusion and 22 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Germany, Italy, United Kingdom, Netherlands and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Event Free Rate (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?
On the ClinicalTrials.gov record for NCT04250714, which also lists 2 linked publications.
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 4 Apr 2025; AzTrials last refreshed its copy on 28 Oct 2026.