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Completed

NCT Number: NCT06123130

AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

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.

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Key information

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Disease Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piedmont Heart Institute, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: HeartBeam AIMIGo VECG System

Primary outcomes

  1. Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L

    Time frame: 30 seconds recording

    Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device.

  2. Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L

    Time frame: 30 seconds recording

    Quantitative analysis on ECG amplitudes of the median beat of a 30s simultaneously recorded ECG from study and reference device.

Secondary outcomes

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

    Time frame: 30 seconds recording

    Summary statistics demonstrating agreement on arrhythmia diagnoses between the two devices will be performed

Sponsors and collaborators

Lead sponsor

HeartBeam, Inc.

Industry

Registry information

Official study title

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

Acronym: VALID-ECG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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