Clinical trial NCT06123130: AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
Official title: Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Atrial Flutter
Bradycardia
Tachycardia
Keywords: Telemedicine
Cardiac Arrhythmia
ECG
Synthesis Software
Diagnostic
Vectorcardiography
Remote Monitoring
Lead sponsor: HeartBeam, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L
timeFrame: 30 seconds recording
measure: Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
timeFrame: 30 seconds recording
Secondary outcomes:
measure: Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.
timeFrame: 30 seconds recording
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Tucker
country: United States
facility: Atlanta Heart Specialists
state: Georgia
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Queens
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
Study officials:
affiliation: HeartBeam, Inc.
name: Peter J. Fitzgerald, MD, PhD
role: STUDY_DIRECTOR
References: