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

H

HeartBeam

Status

Not yet enrolling

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 estimated 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)

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)

Trial contacts and locations

0

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Central trial contact

Pooja Chatterjee

Data sourced from clinicaltrials.gov

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