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NCT04462653
Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder
NA trial testing Wearable Dynamic ECG Recorder in Atrial Fibrillation in 114 participants. Status unknown.
1 August 2020
Quick facts
| Lead sponsor | Huami Corporation |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 114 |
| Start date | 24 April 2020 |
| Primary completion | 1 August 2020 |
| Estimated completion | 1 September 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Wearable Dynamic ECG Recorder
- 12-lead ECG recordings
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Huami Corporation
Who can join
Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device. In this investigation, the following indicators is also evaluated: 1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. 2. Waveform qualitative assessment 3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04462653
- 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 NCT04462653 (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 Huami Corporation
- Last refreshed: 8 July 2020
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/NCT04462653.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing