NCT06123130

AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: HeartBeam, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-13
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2023-11-08
• Last updated: 2024-07-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study