An interventional study of Vectorcardiography (VECG) in Arrhythmias, Cardiac, Atrial Fibrillation and Atrial Flutter, sponsored by HeartBeam, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by HeartBeam, Inc. · Not applicable, Interventional, and Diagnostic
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.
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.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 198 is above the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →HeartBeam, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Also known as: HeartBeam AIMIGo VECG System
Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L
Quantitative analysis on ECG intervals of the median beat of a 30s simultaneously recorded ECG from study and reference device.
Time frame: 30 seconds recording
Clinical equivalence of ECG amplitudes compared between AIMIGo Synthesized 12L and reference standard 12L
Quantitative analysis on ECG amplitudes of the median beat of a 30s simultaneously recorded ECG from study and reference device.
Time frame: 30 seconds recording
Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.
Summary statistics demonstrating agreement on arrhythmia diagnoses between the two devices will be performed
Time frame: 30 seconds recording
Plan to share: No
Ran from Mar 2024 to primary completion in Jun 2024, 3 months.
Of 71 industry-sponsored interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 3 months is below that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HeartBeam, Inc.