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

NCT07353710 | Not Yet Recruiting

• 1 other identifier: PF339
• Study Type: interventional
• Target: 200
• Locations: 8 countries
• Sites: 8

Brief 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.

Conditions

Intracardiac Echocardiography; Atrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects with at least one ICE image collected with the investigational system

Device: ICE Image Acquisition

Interventions

ICE Image Acquisition DEVICE

ICE image acquisition using the investigational device

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (8)

Lingard Private Hospital

Merewether, Australia

Location

Klinicki Bolnicki Centar Split

Split, Croatia

Location

IKEM - Institut klinicke a experimentalni mediciny

Prague, Czechia

Location

Hygeia Hospital

Athens, Greece

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

Auckland City Hospital

Auckland, New Zealand

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland

Location

National Heart Center Singapore

Singapore, Singapore

Location

Central Study Contacts

Nele Cielen

CONTACT

0470991143; nele.cielen@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); NZ (1); CR (1); SG (1); GR (1); AU (1); PL (1); CZ (1)