Atrial ArrhythmiaSONAR-ICENCT07353710
A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
A study testing ICE Image Acquisition in people with Atrial Arrhythmia and Intracardiac Echocardiography, run by Boston Scientific Corporation at 8 sites in 8 countries.
Trial summary
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Arrhythmia, Intracardiac Echocardiography
- What is being tested?
- ICE Image Acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 28 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 who are able and willing to provide written informed consent prior to any study procedure.
- Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice.
- Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation 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 of the following cardiac implanted devices
- Any prosthetic mitral or tricuspid heart valve, such as ring, repairs or clips
- Atrial septal defect (ASD) occluders including interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder
- Subjects with contraindications related to the use of the CHORUS IDx™ System:
- Subjects with inadequate vascular access
- Subjects with active systemic infection
Show all 10Show fewer
- Subjects with presence of a known intracardiac thrombus in the chamber of use
- Women who are confirmed to be pregnant or lactating at the time of the Index Procedure
- Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study
- 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
8 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 8 countries
Australia1 site, 1 recruiting
- Recruiting
Lingard Private Hospital
Merewether
Bradley Wilsmore, MD
Croatia1 site, 1 recruiting
- Recruiting
Klinicki Bolnicki Centar Split
Split
Ante Anic, MD
Czechia1 site, 1 recruiting
- Recruiting
IKEM - Institut klinicke a experimentalni mediciny
Prague
Jozef Kautzner, MD
Greece1 site, 1 recruiting
- Not yet recruiting
Hygeia Hospital
Athens
Stylianos Tzeis, MD
Malaysia1 site, 1 recruiting
- Not yet recruiting
Institut Jantung Negara
Kuala Lumpur
Azlan Hussin, MD
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland City Hospital
Auckland
Andrew Martin, MD
Poland1 site, 1 recruiting
- Not yet recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw
Jakub Baran, MD
Singapore1 site, 1 recruiting
- Recruiting
National Heart Center Singapore
Singapore
Chi-Keong Ching, MD
About this study
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.
- Conditions
- Atrial Arrhythmia, Intracardiac Echocardiography
- Being tested
- ICE Image Acquisition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE Image AcquisitionDevice
ICE image acquisition using the investigational device
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects with at least one ICE image collected with the investigational system Receives: Device: ICE Image Acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of procedure related serious adverse events and all adverse events
Incidence of safety events that have occurred in subjects in whom the investigational device has been inserted, including:
- Index Procedure related serious adverse events up to day 7 after the Index Procedure
- All adverse events
Note: Imaging data will be used for development and validation of the software.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start28 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353710
- Sponsor's protocol ID
- PF339
- Acronym
- SONAR-ICE
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
- ClinicalTrials.gov ID
- NCT07353710
- Acronym / sponsor ID
- SONAR-ICE / PF339
- Conditions
- Atrial Arrhythmia, Intracardiac Echocardiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: ICE Image AcquisitionSubjects with at least one ICE image collected with the investigational system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who are able and willing to provide written informed consent prior to any study procedure.
- Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice.
- Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation 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 (10 listed)
- Any of the following cardiac implanted devices
- Subjects with contraindications related to the use of the CHORUS IDx™ System:
- Women who are confirmed to be pregnant or lactating at the time of the Index Procedure
- Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study
- 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
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 |
|---|---|---|
| ICE Image AcquisitionICE image acquisition using the investigational device | Device | Treatment |
Primary outcome
The incidence of procedure related serious adverse events and all adverse events
Time frame: 7 Days
Incidence of safety events that have occurred in subjects in whom the investigational device has been inserted, including: * Index Procedure related serious adverse events up to day 7 after the Index Procedure * All adverse events Note: Imaging data will be used for development and validation of the software.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Arrhythmia
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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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.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE Image Acquisition in people with Atrial Arrhythmia and Intracardiac Echocardiography, run by Boston Scientific Corporation at 8 sites in 8 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 10 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Croatia, Czechia, Greece, Malaysia and 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nele Cielen (0470991143 ext. 0032, nele.cielen@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of procedure related serious adverse events and all adverse events (time frame: 7 Days). 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 22 Oct 2026.