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
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