A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
Condition(s) studied
Investigational drug(s) / intervention(s)
ICE Image Acquisition: ICE image acquisition using the investigational device
Study 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.
Eligibility
Primary outcome measure(s)
- The incidence of procedure related serious adverse events and all adverse events — 7 Days
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.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Lingard Private Hospital | Merewether | Australia | Not Yet Recruiting |
| Klinicki Bolnicki Centar Split | Split | Croatia | Recruiting |
| IKEM - Institut klinicke a experimentalni mediciny | Prague | Czechia | Not Yet Recruiting |
| Hygeia Hospital | Athens | Greece | Not Yet Recruiting |
| Institut Jantung Negara | Kuala Lumpur | Malaysia | Not Yet Recruiting |
| Auckland City Hospital | Auckland | New Zealand | Not Yet Recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | Poland | Not Yet Recruiting |
| National Heart Center Singapore | Singapore | Singapore | Recruiting |
More Boston Scientific Corporation trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07353710 on ClinicalTrials.gov ↗ ← All trials in Australia