AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

Not Applicable

Completed

• Conditions: Arrhythmias, Cardiac; Tachycardia; Atrial Flutter; Bradycardia; Atrial Fibrillation
• Interventions: Device: Vectorcardiography (VECG)

• Registration Number: NCT06123130
• Lead Sponsor: HeartBeam, Inc.

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.

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 Timeline

• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-08
• Study Start: 2024-03-13
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Vectorcardiography (VECG)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Atlanta Heart Specialists; 🇺🇸 Tucker, Georgia, United States

Long Island Jewish Medical Center; 🇺🇸 Queens, New York, United States

Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States