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

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 Overview

• Status: Not yet recruiting
• Conditions: Atrial Arrhythmia; Intracardiac Echocardiography
• Intervention / Treatment: Device: ICE Image Acquisition

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nele Cielen; Phone Number: 0032 0470991143; Email: nele.cielen@bsci.com

Study Locations

• Australia
  • Merewether, Australia
    • Lingard Private Hospital
    • Contact: Bradley Wilsmore, MD
• Croatia
  • Split, Croatia
    • Klinicki bolnicki centar Split
    • Contact: Ante Anic, MD
• Czechia
  • Prague, Czechia
    • IKEM - Institut klinicke a experimentalni mediciny
    • Contact: Jozef Kautzner, MD
• Greece
  • Athens, Greece
    • Hygeia Hospital
    • Contact: Stylianos Tzeis, MD
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institut Jantung Negara
    • Contact: Azlan Hussin, MD
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
    • Contact: Andrew Martin, MD
• Poland
  • Warsaw, Poland
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
    • Contact: Jakub Baran, MD
• Singapore
  • Singapore, Singapore
    • National Heart Center Singapore
    • Contact: Chi-Keong Ching, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects who are able and willing to provide written informed consent prior to any study procedure.
2. 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.
3. Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation center.
4. 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:

1. 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

2. 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
3. Women who are confirmed to be pregnant or lactating at the time of the Index Procedure
4. Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects with at least one ICE image collected with the investigational system	Device: ICE Image Acquisition; ICE image acquisition using the investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 Days

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PF339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No