Data Collection for Echocardiography-Based Software Assessment

Anumana

Status: Completed

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

Treatments: Other: No investigational intervention administered

Study type: Observational

Funder types: Industry

Identifiers

NCT07126600

DOC-2499

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

LAAC Patient Cohort

Description:

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.

Treatment:

Other: No investigational intervention administered