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The SMART-LV Pilot Study

NCT05630170 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-24

No results posted yet for this study

Summary

The goal of this pilot study is to evaluate the prospective performance of an image-based, smartphone-adaptable artificial intelligence electrocardiogram (AI-ECG) strategy to predict and detect left ventricular systolic dysfunction (LVSD) in a real-world setting.

Conditions

  • Left Ventricular Systolic Dysfunction

Interventions

DEVICE

AI-ECG

A novel AI-ECG model developed at the Cardiovascular Data Science (CarDS) lab will be used as Software as Medical Device (SaMD) on ECG images for detection of LVSD.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Rohan Khera, MD, MS · Yale University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2024-05-21
Completion
2024-05-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630170 on ClinicalTrials.gov