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Data Collection for Echocardiography-Based Software Assessment

NCT ID: NCT07126600

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-11

Study Completion Date

2025-12-17

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Left Atrial Appendage Closure Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No investigational intervention administered

Intervention Type OTHER

No investigational intervention administered

Interventions

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No investigational intervention administered

No investigational intervention administered

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anumana, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leon Ptaszek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Arrhythmia Research Group

Jonesboro, Arkansas, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Southcoast Hospital

New Bedford, Massachusetts, United States

Site Status

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Site Status

University of Buffalo

Amherst, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DOC-2499

Identifier Type: -

Identifier Source: org_study_id