NCT06713226

Clinical Performance Evaluation of the Hativ P30

Prospective, Multi-center, Pre-market, Assessor-blinded Study to Evaluate the Clinical Performance of the Hativ P30 Electrocardiogram Recorder Device

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VUNO Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
DEVICE	Hativ P30 and 12-lead ECG comparator device	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.

Timeline

• Start date: 2025-06-16
• Primary completion: 2025-07-23
• Completion: 2025-07-23
• First posted: 2024-12-03
• Last updated: 2026-02-18

Regulatory

• FDA-regulated device study