Data Collection for Echocardiography-Based Software Assessment
A Data Collection Study for Echocardiography-Based Software Assessment
1 other identifier
observational
100
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2025
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2025
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2025
CompletedDecember 24, 2025
December 1, 2025
4 months
July 28, 2025
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of Imaging-Derived Measurements
Comparison of left atrial appendage measurements (millimeters) from two imaging modalities against a CT-based reference standard.
At the time of imaging assessment (single study visit)
Study Arms (1)
LAAC Patient Cohort
Participants undergoing standard-of-care imaging as part of a left atrial appendage closure (LAAC) procedure. Data will be collected prospectively for software validation purposes.
Interventions
No investigational intervention administered
Eligibility Criteria
Adults undergoing a standard cardiac procedure as part of routine clinical care.
You may qualify if:
- Undergoing a standard left atrial appendage closure procedure with associated imaging.
You may not qualify if:
- Did not provide authorization to use data for research purposes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anumana, Inc.lead
Study Sites (6)
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Southcoast Hospital
New Bedford, Massachusetts, 02740, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
University of Buffalo
Amherst, New York, 14228, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leon Ptaszek, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 17, 2025
Study Start
July 11, 2025
Primary Completion
November 19, 2025
Study Completion
December 17, 2025
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share