Actively Recruiting
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
Led by KARDI AI Technologies s.r.o. · Updated on 2025-06-12
115
Participants Needed
2
Research Sites
14 weeks
Total Duration
On this page
Sponsors
K
KARDI AI Technologies s.r.o.
Lead Sponsor
F
Fakultní nemocnice Olomouc
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 18 years
- Signed informed consent and willingness to cooperate
- Confirmed or suspected heart rhythm disorder
- Ability to use a smartphone and the Kardi Ai mobile app
- Mobile phone meets minimum requirements for the Kardi Ai app
You will not qualify if you...
- Confirmed pregnancy
- Allergic reactions to materials used in clothing or textiles
- Superficial wound or skin irritation at the chest belt attachment site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fakultní nemocnice Olomouc
Olomouc, Czechia, Czechia, 779 00
Actively Recruiting
2
Fakultní nemocnice Ostrava
Ostrava, Czechia, Czechia, 708 52
Actively Recruiting
Research Team
D
David Skála
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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