MedTrace Logo

AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

NCT06123130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-07-05

No results posted yet for this study

Summary

The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.

Conditions

Interventions

DEVICE

Vectorcardiography (VECG)

Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG.

Sponsors & Collaborators

  • HeartBeam, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter J. Fitzgerald, MD, PhD · HeartBeam, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2024-06-20
Completion
2024-06-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06123130 on ClinicalTrials.gov