ArticleEuropean heart journal. Digital health2021
Clinical validation and evaluation of a novel six-lead handheld electrocardiogram recorder compared to the 12-lead electrocardiogram in unselected cardiology patients (EVALECG Cardio).
Article in European heart journal. Digital health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- KardiaMobile 6L for measuring QT interval in people having antipsychotic medication to inform early value assessment: a systematic review.Health technology assessment (Winchester, England) · 2024Pooled it
- Feasibility and accuracy of mobile QT interval monitoring strategies in bedaquiline-enhanced prophylactic leprosy treatment.Clinical and translational science · 2024Trial
- Annual assessment of ECG intervals in patients with myotonic dystrophy type 1 using a mobile 6‑lead ECG device: TeleCheck-DM1.International journal of cardiology. Heart & vasculature · 2026Article
- Multi-Tier Validation of a Single-Lead Wearable ECG Signal-Processing Pipeline: Clinical Comparison and Algorithmic Benchmarking on Public Expert-Annotated Databases.Sensors (Basel, Switzerland) · 2026Article
- Prediction of Atrial Fibrillation Occurrence With Handheld Mobile Electrocardiogram: Deep Learning Model Development Using Real-World Data.JMIR medical informatics · 2026Article
- Comparative analysis of 6-lead and single-lead consumer-grade electrocardiograms: diagnostic accuracy, numerical agreement, and inter-rater reliability.European heart journal. Digital health · 2026Article
- Position-wise comparison of handheld 6-lead ECG versus the standard 12-lead ECG in patients with arrhythmia: comparative study.BMC cardiovascular disorders · 2026Article
- Innovative Advances in Non-Invasive Detection Technologies for Heart Failure: Synergistic Application of Multimodal Sensing and Intelligent Algorithms.Reviews in cardiovascular medicine · 2026Review
- Artificial Intelligence Powered Wearable and Portable Devices for Remote Cardiac Care and Population Health.Current cardiology reports · 2026Review
- Systematic benchmark of reduced-lead configurations for 12-lead ECG reconstruction: multi-model evaluation across all possible subsets.Frontiers in cardiovascular medicine · 2026Article
- Validation of a handheld electrocardiogram 6 lead recorder to obtain chest lead equivalents: An Africa Heart Rhythm Association study.Heart rhythm O2 · 2025Article
- Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals.Contemporary clinical trials communications · 2025Article
- At-Home Self-Collection of Pharmacokinetic Data: Design and Results From a Phase 1 Open-Label Feasibility Trial.Clinical pharmacology in drug development · 2025Article
- Utility and acceptability of remote 6-lead electrocardiographic monitoring in children with inherited cardiac conditions.Archives of disease in childhood · 2024Article
- Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings.JAMA network open · 2024Article
- Use of digital health technologies in periprocedural pediatric cardiac ablation.Cardiovascular digital health journal · 2024Article
- A single-lead ECG based cardiotoxicity detection in patients on polychemotherapy.International journal of cardiology. Heart & vasculature · 2024Article
- What training should psychiatrists have to interpret six- and 12-lead electrocardiograms?BJPsych bulletin · 2023Article
- Accuracy of mobile 6-lead electrocardiogram device for assessment of QT interval: a prospective validation study.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2023Article
- Mobile Health Technology: (Smart)Watch and Wait.JACC. Case reports · 2023Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Aims: Handheld electrocardiogram (ECG) monitors are increasingly used by both healthcare workers and patients to diagnose cardiac arrhythmias. There is a lack of studies validating the use of handheld devices against the standard 12-lead ECG. The Kardia 6L is a novel handheld ECG monitor which can produce a 6-lead ECG. In this study, we compare the 6L ECG against the 12-lead ECG. Methods and results: A prospective study consisting of unselected cardiac inpatients and outpatients at Leeds Teaching Hospital NHS Trust. All participants had a 12- and 6-lead ECGs. All ECG parameters were analysed by using a standard method template for consistency between independent observers. Electrocardiograms from the recorders were compared by the following statistical methods: linear regression, Bland-Altman, receiver operator curve, and kappa analysis. There were 1015 patients recruited. The mean differences between recorders were small for PR, QRS, cardiac axis, with receiver operator analysis area under the curve (AUC) of >80%. Mean differences for QT and QTc (between recorders) were also small, with AUCs for QT leads of >75% and AUCs for QTc leads of >60%. Key findings from Bland-Altman analysis demonstrate overall an acceptable agreement with few outliers instances (<6%, Bland-Altman analysis). Conclusion: Several parameters recorded by the Kardia 6L (QT interval in all six leads, rhythm detection, PR interval, QRS duration, and cardiac axis) perform closely to the gold standard 12-lead ECG. However, that consistency weakens for left ventricular hypertrophy, QRS amplitudes (Lead I and AVL), and ischaemic changes.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.