Clinical Performance Evaluation of the Hativ P30

Launched by VUNO INC. · Nov 26, 2024

Keywords

ClinConnect Summary

The clinical trial is evaluating a new device called the Hativ P30, which is designed to record and analyze heart rhythms using a technology called electrocardiography (ECG). This device can capture heart activity in different ways and transfer the information to a smartphone app. The goal of the study is to determine how safe and effective the Hativ P30 is, and to collect the necessary information to seek approval from health authorities for its wider use.

To participate in the trial, you need to be at least 18 years old and able to give consent. There are specific health criteria for two groups: one group must have a normal heart rhythm and no history of heart problems, while the other group can have certain types of arrhythmias (irregular heartbeats). Participants will undergo ECG recordings and can expect to use the Hativ P30 device while remaining still for about 20 minutes. It's important to note that individuals with certain medical devices or conditions that may interfere with the device's function or the study process will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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