Not Yet RecruitingNot Applicable

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

Australia, Croatia, Czechia200 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Any of the following cardiac implanted devices
✕. Subjects with contraindications related to the use of the CHORUS IDx™ System:
✕. 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

What they're measuring

The incidence of procedure related serious adverse events and all adverse events

Timeframe: 7 Days

Trial details

NCT IDNCT07353710

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Nele Cielen

0470991143 nele.cielen@bsci.com

View on ClinicalTrials.gov More Atrial Arrhythmia trials