Atrial Fibrillation, Cardiovascular Diseases, Left Atrial Appendage Closure
Conditions
Brief summary
This is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool. No investigational procedures or treatments are introduced, and all data are obtained as part of standard-of-care activities.
Detailed description
This is a prospective, observational study designed to collect data from routine clinical procedures related to a specific cardiac intervention. Data will be collected from multiple sites and compiled into a centralized dataset. The dataset will be used to support the evaluation of software-based tools intended to assist in clinical decision-making. No investigational interventions are introduced as part of the study, and all activities align with standard-of-care practices at participating institutions. The study may also support future analyses related to the performance and usability of the software.
Interventions
OTHERNo investigational intervention administered
No investigational intervention administered
Sponsors
Anumana, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing a standard left atrial appendage closure procedure with associated imaging.
Exclusion criteria
* Did not provide authorization to use data for research purposes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Imaging-Derived Measurements | At the time of imaging assessment (single study visit) | Comparison of left atrial appendage measurements (millimeters) from two imaging modalities against a CT-based reference standard. |
Countries
United States
Outcome results
None listed