Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HeartBeam, Inc.
- Enrollment
- 198
- Locations
- 5
- Primary Endpoint
- Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Vectorcardiography (VECG) (Device)
Outcomes
Primary Outcomes
Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
Time Frame: 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
Time Frame: 30 seconds recording
Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device.
Secondary Outcomes
- Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.(30 seconds recording)