Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
Recruiting · NCT07018648 · Interventional (participants receive a specific treatment) · Lead sponsor: KARDI AI Technologies s.r.o.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Confirmed pregnancy
- Allergic reactions to standard substances used in manufacture of clothing or other textiles
- Superficial wound or skin irritation at the site of the chest belt attachment
Where it is running
2 locations listed.
- Fakultní nemocnice Olomouc - Olomouc, Czechia, Czechia
- Fakultní nemocnice Ostrava - Ostrava, Czechia, Czechia