AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection (VALID-ECG)

Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Bradycardia; Tachycardia; Atrial Flutter
• Intervention / Treatment: Device: Vectorcardiography (VECG)

Detailed Description

The purpose of this study is to conduct clinical validation of the AIMIGo 12-lead Synthesis Software against a standard FDA-cleared 12-lead ECG system, based on quantitative and qualitative assessment of paired recordings from the same patient, in sinus rhythm or during episodes of symptomatic non-life-threatening arrhythmia. The study will provide the necessary data for an FDA 510(k) regulatory submission and develop experience for market access and integration into clinical workflows.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Tucker, Georgia, United States, 30084
      • Atlanta Heart Specialists
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • Queens, New York, United States, 11040
      • Long Island Jewish Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects over 18 years of age.

2. Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:

   1. Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation.
   2. Patients with symptoms indicative of cardiac arrhythmias.
3. Able and willing to sign informed consent.

Exclusion Criteria:

1. Open chest wounds or recent (<30 days) surgery to the chest or abdomen.
2. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinic.	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.; Other Names: HeartBeam AIMIGo VECG System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L	Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device.	30 seconds recording
Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L	Quantitative analysis on ECG amplitudes of the median beat of a 30s simultaneously recorded ECG from study and reference device.	30 seconds recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.	Summary statistics demonstrating agreement on arrhythmia diagnoses between the two devices will be performed	30 seconds recording

Collaborators and Investigators

• Sponsor: HeartBeam, Inc.
• Collaborators: Meditrial USA Inc.
• Investigators: Study Director: Peter J. Fitzgerald, MD, PhD, HeartBeam, Inc.

Publications and helpful links

Helpful Links

• HeartBeam Website

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Diagnostic; Remote Monitoring; ECG; Cardiac Arrhythmia; Vectorcardiography; Synthesis Software
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Atrial Fibrillation; Bradycardia; Arrhythmias, Cardiac; Tachycardia; Atrial Flutter
• Other Study ID Numbers: HB-VECG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Publication
   Information comments: Coronary Artery Occlusion Detection Using 3-Lead ECG System Suitable for Credit Card-Size Personal Device Integration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No