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

Sponsor

HeartBeam, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06123130

Collaborator

Meditrial USA Inc. (Other)

150

Enrollment

Location

Arm

Anticipated Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Bradycardia Tachycardia	Device: Vectorcardiography (VECG)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Composite endpoint measured as differences in intervals/durations and amplitudes between standard 12L ECG and AIMIGo synthesized 12L ECG taken simultaneously [1 day]
Intervals: PQ, QRS, QT, RR Amplitudes: P-wave, R-wave, T-wave Measured on median beats

Secondary Outcome Measures

Clinical diagnostic accuracy [1 day]
Measured by Sensitivity and Specificity of synthesized 12L ECG compared with the standard 12L ECG for the classification of arrythmia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.