Arrhythmias, CardiacVALID-ECGNCT06123130
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
A study testing Vectorcardiography (VECG) in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by HeartBeam, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Vectorcardiography (VECG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Mar 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
The Mount Sinai Hospital
New York, New York, 10029
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Long Island Jewish Medical Center
Queens, New York, 11040
Atlanta Heart Specialists
Tucker, Georgia, 30084
About this study
Official title: Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
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.
Read the 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.
- Being tested
- Vectorcardiography (VECG)
- Keywords
- Telemedicine, Cardiac Arrhythmia, ECG, Synthesis Software, Diagnostic, Vectorcardiography, Remote Monitoring
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vectorcardiography (VECG)Device
Also called HeartBeam AIMIGo VECG System
Patients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 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. Receives: Device: Vectorcardiography (VECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 seconds recording
Secondary outcomes (1)
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
Measured: 30 seconds recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start13 Mar 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeartBeam, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J. Fitzgerald, MD, PhD, Study director, HeartBeam, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123130
- Sponsor's protocol ID
- HB-VECG-001
- Acronym
- VALID-ECG
- Status last verified
- Jul 2024
- First submitted
- 5 Nov 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study
- ClinicalTrials.gov ID
- NCT06123130
- Acronym / sponsor ID
- VALID-ECG / HB-VECG-001
- Keywords
- Telemedicine, Cardiac Arrhythmia, ECG, Synthesis Software, Diagnostic, Vectorcardiography, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- HeartBeam, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Vectorcardiography (VECG)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Able and willing to sign informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vectorcardiography (VECG)Also: HeartBeam AIMIGo VECG SystemPatients enrolled will undergo diagnostic ECG recording: three sets of simultaneous 30s recordings with the investigational device AIMIGo and a standard 12L ECG. | Device | Single Arm |
Primary outcome
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.
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.
1 secondary outcome
Clinical diagnostic accuracy of AIMIGo Synthesized 12L compared with the reference standard 12L ECG for the classification of arrhythmia.
Time frame: 30 seconds recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- HeartBeam WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J. Fitzgerald, MD, PhD study director
HeartBeam, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vectorcardiography (VECG) in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by HeartBeam, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical equivalence of ECG intervals compared between AIMIGo Synthesized 12L and reference standard 12L (time frame: 30 seconds recording). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.