Last reviewed · How we verify
NCT03477734
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
NA trial testing CS1 & heart monitor in Atrium; Fibrillation in 53 participants. Completed in 9 June 2020.
25 November 2019
Quick facts
| Lead sponsor | CardiacSense Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 53 |
| Start date | 20 February 2019 |
| Primary completion | 25 November 2019 |
| Estimated completion | 9 June 2020 |
| Sites | 2 locations across Israel |
Drugs / interventions tested
- CS1 & heart monitor
Conditions studied
- Atrium; Fibrillation — all drugs for Atrium; Fibrillation →
Sponsor
CardiacSense Ltd.
Who can join
Adults 18 to 85, any sex, with Atrium; Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation. The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG 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 NCT03477734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrium; Fibrillation
Currently open trials in the same condition.
- NCT06829589 — Retrieval of Economic Incentives and Information on Quality-of-care Indicators in Primary Care · NA · active not recruiting
- NCT05434650 — Abbott Atrial Fibrillation Post Approval Study · active not recruiting
- NCT05633303 — Personalised Ablation Strategies in AF · NA · recruiting
Other CardiacSense Ltd. trials
Trials by the same sponsor.
- NCT05591157 — Evaluation of CSF-3 in Performing ECG · NA · completed
- NCT05322382 — Accuracy of Pulse Oximeters With Profound Hypoxia · NA · completed
- NCT05370066 — Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose Measurement of Blood Pressure · NA · unknown
- NCT05723744 — Anonymized Data Collection From the CS6BP for Heart Arrythmias Measurements · NA · completed
- NCT04215185 — Data Collection of BP Values by CS6BP · NA · unknown
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 NCT03477734 (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 CardiacSense Ltd.
- Last refreshed: 21 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/NCT03477734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing