Acquiring 2D ICE Images with the CHORUS IDx System During Atrial Arrhythmia Ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human prospective study collects human ICE images during planned ablation procedures for atrial arrhythmias to support software development. Participants are adults undergoing ablation with a Boston Scientific commercial system, and consent is obtained prior to any study procedures. The study focuses on acquiring ICE images using the CHORUS IDx system as part of routine clinical workflow at participating centers. Data collection is tied to standard practice and site-specific investigations. No efficacy outcomes are described beyond the imaging data collection for software purposes.

Why it matters

Who can join: the full rules

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

Where it's running

• Lingard Private Hospital
  Merewether, Australia Recruiting
• Klinicki Bolnicki Centar Split
  Split, Croatia Recruiting
• IKEM - Institut klinicke a experimentalni mediciny
  Prague, Czechia Recruiting
• National Heart Center Singapore
  Singapore, Singapore Recruiting
• Hygeia Hospital
  Athens, Greece Not yet recruiting
• Institut Jantung Negara
  Kuala Lumpur, Malaysia Not yet recruiting

Study contacts

• Study coordinator: Nele Cielen
• Email: nele.cielen@bsci.com
• Phone: 0470991143

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.