Testing an AI heart rhythm monitor using a chest strap in adults
Tests a device that uses AI to check heart rhythm disorders in adults.
Plain-language title generated from the registry record
Registry title: Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
Key facts
- Where
- Olomouc and Ostrava, CzechiaSee the 2 sites
Where in Czechia
- Fakultni nemocnice OlomoucOlomouc, CzechiaTaking people
- Fakultni nemocnice OstravaOstrava, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- KARDI AI Technologies s.r.o.
- Trial code
- NCT07018648
- Record updated
- 12 June 2025
- Original description
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.Read full original descriptionShow less
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System Using Artificial Intelligence to Evaluate ECGs Measured by Hardware Component (POLAR H10 Chest Strap)
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.
The main questions it aims to answer are:
* What is the sensitivity and specificity of Kardi Ai device for all monitored heart rythm disorders (combined) * What is the sensitivity and specificity of Kardi Ai device for each of the monitored heart rythm disorders * What is the quality of the ECG recordings
Participants will receive Kardi Ai medical device. They will use it to collect ECG recordings from at least 5 different days and in total collect records of at least 10 hours duration.
Inclusion: Age above 18 years; Signed informed consent/willingness to cooperate; Confirmed or suspected heart rhythm disorder of a cardiac rhythm disorder; Ability to use a smartphone and mobile app Kardi Ai; The subject's mobile phone meets the minimum requirements for the Kardi Ai app to work.
Exclusion: Allergic reactions to standard substances used in manufacture of clothing or other textiles; Confirmed pregnancy; Superficial wound or skin irritation at the site of the chest belt attachment.