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The SMART-LV Pilot Study

N/A
Waitlist Available
Led By Rohan Khera, MD, MS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during study visit approximately 50 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a smartphone tool to detect heart problems, like LVSD, in everyday life.

Who is the study for?
This trial is for individuals who can give informed consent and are willing to follow the study procedures. It's not for those with a known heart failure diagnosis, prior low ejection fraction (EF), or previous echocardiograms, nor for patients with an intermediate chance of low EF.
What is being tested?
The SMART-LV Pilot Study is testing an AI-powered electrocardiogram (AI-ECG) that works with smartphones to predict and detect left ventricular systolic dysfunction in real-world conditions.
What are the potential side effects?
Since this study involves non-invasive AI-ECG monitoring, there are minimal expected side effects. However, some participants might experience discomfort or anxiety during ECG recording.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during study visit approximately 50 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and during study visit approximately 50 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Successful detection of asymptomatic LVSD by AI-ECG

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AI-ECGExperimental Treatment1 Intervention
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.The AI-ECG model will be used on all participants undergoing a 12-lead ECG.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AI-ECG
2023
N/A
~10

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,464 Total Patients Enrolled
Rohan Khera, MD, MSPrincipal InvestigatorYale University

Media Library

AI-ECG Clinical Trial Eligibility Overview. Trial Name: NCT05630170 — N/A
Left Ventricular Dysfunction Research Study Groups: AI-ECG
Left Ventricular Dysfunction Clinical Trial 2023: AI-ECG Highlights & Side Effects. Trial Name: NCT05630170 — N/A
AI-ECG 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630170 — N/A
~4 spots leftby Dec 2025
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