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.
Brief Title
Data Collection for Echocardiography-Based Software Assessment
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atrial Fibrillation
Left Atrial Appendage Closure
Cardiovascular Diseases
Eligibility Criteria
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.
* Undergoing a standard left atrial appendage closure procedure with associated imaging.
Exclusion Criteria:
* Did not provide authorization to use data for research purposes.
Inclusion Criteria
Inclusion Criteria:
* Undergoing a standard left atrial appendage closure procedure with associated imaging.
* Undergoing a standard left atrial appendage closure procedure with associated imaging.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07126600
Org Class
Industry
Org Full Name
Anumana, Inc.
Org Study Id
DOC-2499
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Data Collection Study for Echocardiography-Based Software Assessment
Primary Outcomes
Outcome Description
Comparison of left atrial appendage measurements (millimeters) from two imaging modalities against a CT-based reference standard.
Outcome Measure
Comparison of Imaging-Derived Measurements
Outcome Time Frame
At the time of imaging assessment (single study visit)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adults undergoing a standard cardiac procedure as part of routine clinical care.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- ATRIAL FIBRILLATION
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
MeSH Terms
ATRIAL FIBRILLATION
CARDIOVASCULAR DISEASES
ARRHYTHMIAS, CARDIAC
HEART DISEASES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS