Equivalence of ECG Electrode Type Signal Quality for AF and Non AF UsersNCT05357209
Avidhrt Clinical Equivalence Study
A study testing Avidhrt Sense Heart Monitor in people with Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users, run by Avidhrt Inc..
Trial summary
The Avidhrt Clinical Equivalence Study will test and evaluate the equivalency between ECG signals acquired simultaneously using the Avidhrt Sense Lead-1 ECG, and an FDA cleared Lead-12 gel ECG. The Avidhrt Clinical Equivalence Study also includes a sub-study. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users
- What is being tested?
- Avidhrt Sense Heart Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 30 Jul 2022
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 22 years old at the time of enrollment
- Capable of giving informed consent
- Sufficient manual dexterity to capture an ECG using Avidhrt Sense
- Subjects in the arrhythmia group must have a known history of arrhythmia, and may have an arrhythmia at the time of enrollment based on the screening ECG just before the study recordings are taken.
Who cannot join
- Cardiac pacemaker or implantable cardioverter-defibrillator
- History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
- Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
- Subjects in the normal controls group should not have any history of arrhythmia and should not be in arrhythmia at the time of enrollment based on the screening ECG
- Subjects with tremors who are unable to stably hold the Avidhrt Sense during a recording without movement
About this study
Official title: Avidhrt Clinical Equivalence of ECG
The Avidhrt Clinical Equivalence Study will test and evaluate the equivalency between ECG signals acquired simultaneously using the Avidhrt Sense Lead-1 ECG, and an FDA cleared Lead-12 gel ECG. The Avidhrt Clinical Equivalence Study also includes a sub-study. The Avidhrt Sense Human Factors sub-study will evaluate the usability and efficacy of the user-interface of the Avidhrt Sense device.
Read the detailed description
This study will test the clinical equivalency of an Avidhrt Sense acquired Lead-I ECG signal and a Lead-I ECG signal obtained from an FDA cleared 12-lead-ECG gel electrode.The Avidhrt Clinical Equivalence study is comprised of study Arm A and Arm B. In Arm A of this study the population is comprised exclusively of subjects with AF, who will be asked to participate in the Clinical Equivalence Study and in the Human Factors Sub-Study. In Arm B of this study the population will consist of all other subjects (no AF), who will be asked to participate in the Clinical Equivalence Study, with the option to enroll and participate in the Human Factors Sub-Study. This is a prospective, parallel-cohort, non-randomized study using an enriched population.
- Being tested
- Avidhrt Sense Heart Monitor
- Keywords
- ECG Equivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avidhrt Sense Heart MonitorDevice
Use of Avidhrt Sense Heart Monitor review ECG signals.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | Arm A of the Avidhrt study will contain subjects that have been/are diagnosed with AF. Arm A of the study will have the participants complete the Human Factors sub-study in addition to the primary clinical study. Receives: Device: Avidhrt Sense Heart Monitor |
| Arm B | Other | Arm B of the Avidhrt study will contain all other subjects (those non diagnosed with AF), and participants will receive the option whether to participate in the Human Factors sub-study. Receives: Device: Avidhrt Sense Heart Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avidhrt Sense ECG equivalency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 May 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equivalence of ECG Electrode Type Signal Quality for AF and Non AF UsersStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is divided into two arms. Arm A will contain subjects with diagnosed AF, and arm B will contain all other subjects. This is a prospective, parallel-cohort, non-randomized study using an enriched population.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avidhrt Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ASCENSION SACRED HEART, Michigan State University, Spring Arbor University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357209
- Sponsor's protocol ID
- ACES-01
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avidhrt Clinical Equivalence of ECG
- ClinicalTrials.gov ID
- NCT05357209
- Acronym / sponsor ID
- ACES-01
- Keywords
- ECG Equivalence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Avidhrt Inc.Industry (pharma, biotech, devices)
- Collaborators
- ASCENSION SACRED HEART, Michigan State University, Spring Arbor University
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 2 May 2022 (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 Avidhrt Clinical Equivalence Study will test and evaluate the equivalency between ECG signals acquired simultaneously using the Avidhrt Sense Lead-1 ECG, and an FDA cleared Lead-12 gel ECG. The Avidhrt Clinical Equivalence Study also includes a sub-study. The Avidhrt Sense Human Factors sub-study will evaluate the usability and efficacy of the user-interface of the Avidhrt Sense device.
Detailed description
This study will test the clinical equivalency of an Avidhrt Sense acquired Lead-I ECG signal and a Lead-I ECG signal obtained from an FDA cleared 12-lead-ECG gel electrode.The Avidhrt Clinical Equivalence study is comprised of study Arm A and Arm B. In Arm A of this study the population is comprised exclusively of subjects with AF, who will be asked to participate in the Clinical Equivalence Study and in the Human Factors Sub-Study. In Arm B of this study the population will consist of all other subjects (no AF), who will be asked to participate in the Clinical Equivalence Study, with the option to enroll and participate in the Human Factors Sub-Study. This is a prospective, parallel-cohort, non-randomized study using an enriched population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is divided into two arms. Arm A will contain subjects with diagnosed AF, and arm B will contain all other subjects. This is a prospective, parallel-cohort, non-randomized study using an enriched population.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Device: Avidhrt Sense Heart MonitorArm A of the Avidhrt study will contain subjects that have been/are diagnosed with AF. Arm A of the study will have the participants complete the Human Factors sub-study in addition to the primary clinical study. |
| Arm B | Other | Device: Avidhrt Sense Heart MonitorArm B of the Avidhrt study will contain all other subjects (those non diagnosed with AF), and participants will receive the option whether to participate in the Human Factors sub-study. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 22 years old at the time of enrollment
- Capable of giving informed consent
- Sufficient manual dexterity to capture an ECG using Avidhrt Sense
- Subjects in the arrhythmia group must have a known history of arrhythmia, and may have an arrhythmia at the time of enrollment based on the screening ECG just before the study recordings are taken.
Key exclusion criteria (5 listed)
- Cardiac pacemaker or implantable cardioverter-defibrillator
- History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
- Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
- Subjects in the normal controls group should not have any history of arrhythmia and should not be in arrhythmia at the time of enrollment based on the screening ECG
- Subjects with tremors who are unable to stably hold the Avidhrt Sense during a recording without movement
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 |
|---|---|---|
| Avidhrt Sense Heart MonitorUse of Avidhrt Sense Heart Monitor review ECG signals. | Device | Arm A, Arm B |
Primary outcome
Avidhrt Sense ECG equivalency
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Avidhrt Sense Heart Monitor in people with Equivalence of ECG Electrode Type Signal Quality for AF and Non AF Users, run by Avidhrt Inc..
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Avidhrt Sense ECG equivalency (time frame: 12 months). 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 2 May 2022.