NCT07018648Recruiting
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
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)
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 17 May 2025
- Start date
- 19 May 2025
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- KARDI AI Technologies s.r.o.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07018648
What you commit to
- Study type: Interventional
- Planned participants: 115
- From 19 May 2025 to the primary completion date, 1 Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic reactions to standard substances used in manufacture of clothing or other textiles
Other
- Confirmed pregnancy
- Superficial wound or skin irritation at the site of the chest belt attachment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.