About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Subjects with inadequate vascular access
Trial design
Single group
Treatments tested in this trial
ICE Image Acquisition
DeviceICE image acquisition using the investigational device
Treatment groups
Trial outcomes
Primary outcomes
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: * 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.
Sponsors and contacts
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