Data Collection for Echocardiography-Based Software Assessment

Recruiting

• Conditions: Atrial Fibrillation; Left Atrial Appendage Closure; Cardiovascular Diseases

• Registration Number: NCT07126600
• Lead Sponsor: Anumana, Inc.

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.

Study Timeline

• Study Start: 2025-07-11
• Study First Submitted: 2025-07-28
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-10
• Study First Posted: 2025-08-17
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Southcoast Hospital; 🇺🇸 New Bedford, Massachusetts, United States

University of Massachusetts Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States

University of Buffalo; 🇺🇸 Amherst, New York, United States