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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 inadequate vascular access

Trial design

Treatments tested in this trial

  • ICE Image Acquisition

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators