ArrhythmiaNCT06713226
Clinical Performance Evaluation of the Hativ P30
A study testing Hativ P30 and 12-lead ECG comparator device in people with Arrhythmia, run by VUNO Inc..
Trial summary
Hativ P30 is intended to record, store, and transfer one-and two-channel ECG rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, Hativ P30 can record lead-I. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Hativ P30 and 12-lead ECG comparator device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2025to 23 Jul 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older
- Able to provide written informed consent
- Able to remain in the same position for an ECG recording for at least 20 minutes using a standard 12-lead ECG recorder and the Hativ P30 device
- NSR cohort only: no history of arrhythmia
- NSR cohort only: no history of cardiovascular diseases, including but not limited to hypertension, hyperlipidemia, coronary artery disease, heart failure, peripheral artery disease, and stroke
- NSR cohort only: being in NSR at the time of screening ECG
- Arrhythmia cohort only: documented persistent, permanent, or chronic arrhythmia (AF or flutter, sinus rhythm with APB, sinus rhythm with VPB)
- Arrhythmia cohort only: being in arrhythmia (AF or flutter, sinus rhythm with APB, sinus rhythm with VPB) at the time of screening ECG
Who cannot join
- Subjects with an implantable pacemaker device, implantable cardioverter-defibrillator device, or internal simulator that would generate internal interference with the recording of the Hativ P30 device or a standard 12-lead ECG recorder
- Any medical or cognitive condition that would interfere with the consenting process and study-related procedures as determined by the Investigator
- Any known clinical condition (e.g., body tremors, non-healed chest wound, limb absence, etc.) that would preclude appropriate placement of the leads and/or compromise study measurements in the opinion of the Investigator
- Poor 12-lead screening ECG quality
- Pregnant at the time of enrollment
- Participation in other interventional clinical studies that includes active treatment for the last three (3) months (observational studies and long-term follow-up [no active treatment] will be allowed)
- Screening ECG record resulting in a significant arrhythmia out of the scope of the study, such as Supraventricular Tachycardia, Ventricular Tachycardia, Ventricular Fibrillation, Neurocardiogenic Syncope, among others
About this study
Official title: Prospective, Multi-center, Pre-market, Assessor-blinded Study to Evaluate the Clinical Performance of the Hativ P30 Electrocardiogram Recorder Device
Hativ P30 is intended to record, store, and transfer one-and two-channel ECG rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, Hativ P30 can record lead-I. In two-channel mode, Hativ P30 can record lead-I and lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The ECG signal measured through the device's electrode is converted into a digital signal and transmitted via Bluetooth to an Android or iOS-based smart device with a mobile app installed. The ECG signal and analysis result can be checked through the screen of the smart device.
The aim of this clinical study is to assess the safety and efficacy of the Hativ P30 ECG recording device, as well as to gather data to support an FDA submission through the 510(k) process for the device's commercialization.
- Conditions
- Arrhythmia
- Being tested
- Hativ P30 and 12-lead ECG comparator device
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hativ P30 and 12-lead ECG comparator deviceDevice
The purpose of this study is to compare the clinical equivalence and diagnostic ability of the Hativ P30 against the 12-lead ECG comparator device.
Electrocardiograms of all participants will be obtained using both the Hativ P30 and a 12-lead ECG comparator. That is, all participants will get the same intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative assessment and comparison of the two devices
Median beat cross correlation for Lead I and II.
Measured: 30 seconds
Quantitative assessment and comparison of the two devices
QRS amplitude of the median beats of all six limb leads by RMS error.
Measured: 30 seconds
Qualitative assessment and comparison of the two devices
Diagnostic equivalence between Hativ P30 and 12-lead ECG by three cardiologists (NSR, AF or flutter, sinus rhythm with APB, sinus rhythm with VPB).
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start16 Jun 2025 (estimated)
- Primary completion23 Jul 2025 (estimated)
- Study completion23 Jul 2025 (estimated)
Why it stopped: Company's internal decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VUNO Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713226
- Sponsor's protocol ID
- VN-P30-01
- Status last verified
- Jan 2025
- First submitted
- 22 Nov 2024
- Last updated
- 18 Feb 2026
- Results posted
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Pre-market, Assessor-blinded Study to Evaluate the Clinical Performance of the Hativ P30 Electrocardiogram Recorder Device
- ClinicalTrials.gov ID
- NCT06713226
- Acronym / sponsor ID
- VN-P30-01
- Conditions
- Arrhythmia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company's internal decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VUNO Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (estimated)
- Primary completion
- 23 Jul 2025 (estimated)
- Study completion
- 23 Jul 2025 (estimated)
- First posted
- 3 Dec 2024 (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.
Hativ P30 is intended to record, store, and transfer one-and two-channel ECG rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, Hativ P30 can record lead-I. In two-channel mode, Hativ P30 can record lead-I and lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The ECG signal measured through the device's electrode is converted into a digital signal and transmitted via Bluetooth to an Android or iOS-based smart device with a mobile app installed. The ECG signal and analysis result can be checked through the screen of the smart device.
The aim of this clinical study is to assess the safety and efficacy of the Hativ P30 ECG recording device, as well as to gather data to support an FDA submission through the 510(k) process for the device's commercialization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 years or older
- Able to provide written informed consent
- Able to remain in the same position for an ECG recording for at least 20 minutes using a standard 12-lead ECG recorder and the Hativ P30 device
- NSR cohort only: no history of arrhythmia
- NSR cohort only: no history of cardiovascular diseases, including but not limited to hypertension, hyperlipidemia, coronary artery disease, heart failure, peripheral artery disease, and stroke
Key exclusion criteria (7 listed)
- Subjects with an implantable pacemaker device, implantable cardioverter-defibrillator device, or internal simulator that would generate internal interference with the recording of the Hativ P30 device or a standard 12-lead ECG recorder
- Any medical or cognitive condition that would interfere with the consenting process and study-related procedures as determined by the Investigator
- Any known clinical condition (e.g., body tremors, non-healed chest wound, limb absence, etc.) that would preclude appropriate placement of the leads and/or compromise study measurements in the opinion of the Investigator
- Poor 12-lead screening ECG quality
- Pregnant at the time of enrollment
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 |
|---|---|---|
| Hativ P30 and 12-lead ECG comparator deviceThe purpose of this study is to compare the clinical equivalence and diagnostic ability of the Hativ P30 against the 12-lead ECG comparator device. Electrocardiograms of all participants will be obtained using both the Hativ P30 and a 12-lead ECG comparator. That is, all participants will get the same intervention. | Device | – |
Primary outcome
Quantitative assessment and comparison of the two devices
Time frame: 30 seconds
Median beat cross correlation for Lead I and II.
Quantitative assessment and comparison of the two devices
Time frame: 30 seconds
QRS amplitude of the median beats of all six limb leads by RMS error.
Qualitative assessment and comparison of the two devices
Time frame: 30 seconds
Diagnostic equivalence between Hativ P30 and 12-lead ECG by three cardiologists (NSR, AF or flutter, sinus rhythm with APB, sinus rhythm with VPB).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- 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.
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 Hativ P30 and 12-lead ECG comparator device in people with Arrhythmia, run by VUNO 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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Feb 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quantitative assessment and comparison of the two devices (time frame: 30 seconds). The study lists 3 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 18 Feb 2026.