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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects with at least one ICE image collected with the investigational system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICE Image Acquisition | Device | ICE image acquisition using the investigational device |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of procedure related serious adverse events and all adverse events | Incidence of safety events that have occurred in subjects in whom the investigational device has been inserted, including:
Note: Imaging data will be used for development and validation of the software. | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following cardiac implanted devices
Subjects with contraindications related to the use of the CHORUS IDxâ„¢ 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nele Cielen | Contact | 0470991143 | 0032 | nele.cielen@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lingard Private Hospital | Merewether | Australia |
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| Klinicki Bolnicki Centar Split | Split | Croatia |
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| IKEM - Institut klinicke a experimentalni mediciny | Prague | Czechia |
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| Hygeia Hospital | Athens | Greece |
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| Institut Jantung Negara | Kuala Lumpur | Malaysia |
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| Auckland City Hospital | Auckland | New Zealand |
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| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | Poland |
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| National Heart Center Singapore | Singapore | Singapore |
|