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

Boston Scientific

Status: Begins enrollment in 4 months

Conditions: Atrial Arrhythmia; Intracardiac Echocardiography

Treatments: Device: ICE Image Acquisition

Study type: Interventional

Funder types: Industry

Identifiers

NCT07353710

PF339

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Device: ICE Image Acquisition