AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2024-06-20

Brief Summary

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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.

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Detailed Description

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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

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Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Bradycardia Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vectorcardiography (VECG)

Intervention Type DEVICE

Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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HeartBeam AIMIGo VECG System

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No