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NCT Number: NCT07353710

A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lingard Private Hospital, Merewether, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

ICE Image Acquisition

Device

ICE image acquisition using the investigational device

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nele Cielen

CONTACT

[email protected]

0470991143 ext. 0032

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: SONAR-ICE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jul 23, 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.

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