AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

NCT06123130 | Completed FDA Device

• 1 other identifier: HB-VECG-001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 5

Brief 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

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia

Keywords

Telemedicine; Cardiac Arrhythmia; ECG; Synthesis Software; Diagnostic; Vectorcardiography; Remote Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.

  30 seconds recording

Study Arms (1)

Single Arm

EXPERIMENTAL

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)

Interventions

Vectorcardiography (VECG) DEVICE

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

Also known as: HeartBeam AIMIGo VECG System

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects over 18 years of age.
• Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:
• Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation.
• Patients with symptoms indicative of cardiac arrhythmias.
• Able and willing to sign informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• HeartBeam, Inc.: lead

Study Sites (5)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Atlanta Heart Specialists

Tucker, Georgia, 30084, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Long Island Jewish Medical Center

Queens, New York, 11040, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Links

• HeartBeam Website

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Bradycardia; Tachycardia; Disease

Interventions

Vectorcardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Peter J. Fitzgerald, MD, PhD

  HeartBeam, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 8, 2023
• Study Start: March 13, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)