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

August 18, 2026 updated by: Boston Scientific Corporation
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Merewether, Australia
        • Not yet recruiting
        • Lingard Private Hospital
        • Contact:
          • Bradley Wilsmore, MD
  • Croatia
      • Split, Croatia
        • Recruiting
        • Klinički Bolnički Centar Split
        • Contact:
          • Ante Anic, MD
  • Czechia
      • Prague, Czechia
        • Not yet recruiting
        • IKEM - Institut klinicke a experimentalni mediciny
        • Contact:
          • Jozef Kautzner, MD
  • Greece
      • Athens, Greece
        • Not yet recruiting
        • Hygeia Hospital
        • Contact:
          • Stylianos Tzeis, MD
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Not yet recruiting
        • Institut Jantung Negara
        • Contact:
          • Azlan Hussin, MD
  • New Zealand
      • Auckland, New Zealand
        • Not yet recruiting
        • Auckland City Hospital
        • Contact:
          • Andrew Martin, MD
  • Poland
      • Warsaw, Poland
        • Not yet recruiting
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
        • Contact:
          • Jakub Baran, MD
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Heart Center Singapore
        • Contact:
          • Chi-Keong Ching, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 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)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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