AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

HeartBeam, Inc.198 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

198

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Bradycardia Tachycardia

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Piedmont Heart Institute

Atlanta, Georgia, United States

Atlanta Heart Specialists

Tucker, Georgia, United States

The Mount Sinai Hospital

New York, New York, United States

Long Island Jewish Medical Center

Queens, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 seconds recording

Secondary Outcomes

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

Time frame: 30 seconds recording

Data from ClinicalTrials.gov

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