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NCT07018648: Kardi Ai
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
NA trial testing Medical device in Atrial Fibrillation (AF) in 115 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | KARDI AI Technologies s.r.o. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 115 |
| Start date | 19 May 2025 |
| Primary completion | 1 August 2025 |
| Estimated completion | 30 August 2025 |
| Sites | 2 locations across Czechia |
Drugs / interventions tested
- Medical device
Conditions studied
- Atrial Fibrillation (AF) — all drugs for Atrial Fibrillation (AF) →
- Atrial Premature Complexes — all drugs for Atrial Premature Complexes →
- Ventricular Premature Complexes — all drugs for Ventricular Premature Complexes →
- Bradycardia — all drugs for Bradycardia →
Sponsor
KARDI AI Technologies s.r.o.
Who can join
18 and older, any sex, with Atrial Fibrillation (AF) or Atrial Premature Complexes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07018648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07018648 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by KARDI AI Technologies s.r.o.
- Last refreshed: 12 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07018648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing