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NCT05599308
Evaluation of Blood Pressure Monitor With AFib Screening Feature
NA trial testing OMRON blood pressure monitor with AFib screening feature in Atrial Fibrillation in 574 participants. Completed in 11 April 2023.
11 April 2023
Quick facts
| Lead sponsor | Omron Healthcare Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 574 |
| Start date | 6 September 2022 |
| Primary completion | 11 April 2023 |
| Estimated completion | 11 April 2023 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- OMRON blood pressure monitor with AFib screening feature
- Microlife WatchBP Home A
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Omron Healthcare Co., Ltd.
Who can join
22 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Atrial fibrillation: epidemiology, screening and digital health.
Linz D, Gawalko M, Betz K, Hendriks JM, et al · · 2024 · cited 230× · PMID 38362546 · DOI 10.1016/j.lanepe.2023.100786
Verify or expand the search:
- PubMed search for NCT05599308
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
- NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting
Other Omron Healthcare Co., Ltd. trials
Trials by the same sponsor.
- NCT04144699 — Clinical Validation of Omron WheezeScan · unknown
- NCT04084236 — The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain · NA · unknown
- NCT04082156 — The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports · NA · unknown
- NCT03511014 — Efficacy of Microcurrent Therapy for Treatment of Knee Pain · NA · unknown
- NCT03130686 — A Clinical Evaluation of Omron Digital Blood Pressure Monitor · completed
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 NCT05599308 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Omron Healthcare Co., Ltd.
- Last refreshed: 28 April 2023
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/NCT05599308.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing