Atrial Arrhythmia, Intracardiac Echocardiography
Conditions
Brief 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.
Interventions
DEVICEICE Image Acquisition
ICE image acquisition using the investigational device
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 IDx™ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Croatia, Czechia, Greece, Malaysia, New Zealand, Poland, Singapore
Contacts
CONTACTNele Cielen
Outcome results
None listed