AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - anyAllBoston Scientific Corporation
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 IDxโ„ข 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
๐Ÿ’Š

What it tests

  • ICE Image Acquisition
๐Ÿ“

Where

8 sites
Lingard Private Hospital
Merewether, Australia
Klinicki Bolnicki Centar Split
Split, Croatia
IKEM - Institut klinicke a experimentalni mediciny
Prague, Czechia
Hygeia Hospital
Athens, Greece
Institut Jantung Negara
Kuala Lumpur, Malaysia
Auckland City Hospital
Auckland, New Zealand
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
National Heart Center Singapore
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy