AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

Atrial Fibrillation Clinical Trial

— VALID-ECG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06123130
• Other study ID #: HB-VECG-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: HeartBeam, Inc.
• Contact: Pooja Chatterjee
• Phone: 9087459076
• Email: pchatterjee[@]heartbeam.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HeartBeam, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint measured as differences in intervals/durations and amplitudes between standard 12L ECG and AIMIGo synthesized 12L ECG taken simultaneously	Intervals: PQ, QRS, QT, RR; Amplitudes: P-wave, R-wave, T-wave; Measured on median beats	1 day
Secondary	Clinical diagnostic accuracy	Measured by Sensitivity and Specificity of synthesized 12L ECG compared with the standard 12L ECG for the classification of arrythmia	1 day

External Links

•   HeartBeam Website