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

HeartBeam

Status: Completed

Conditions: Bradycardia; Atrial Flutter; Atrial Fibrillation; Tachycardia; Arrhythmias, Cardiac

Treatments: Device: Vectorcardiography (VECG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06123130

HB-VECG-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 1 patient group

Single Arm

Experimental group

Description:

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.

Treatment:

Device: Vectorcardiography (VECG)