Data Collection for Echocardiography-Based Software Assessment

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Left Atrial Appendage Closure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Research Group, Jonesboro, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No investigational intervention administered

Other

No investigational intervention administered

Primary outcomes

Comparison of Imaging-Derived Measurements

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Anumana, Inc.

Industry

Registry information

Official study title

A Data Collection Study for Echocardiography-Based Software Assessment

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 17, 2025
Registry last updated: Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed