Atrial Fibrillation (AF), Cardiac Arrhythmias
Conditions
Keywords
ECG monitoring, wearable devices, atrial fibrillation screening, digital health, patch ECG, elderly population, ambulatory ECG monitoring
Brief summary
This prospective, randomized, multi-arm study evaluates the usability and performance of commercially available CE-certified 7-day ECG patches in an outpatient setting. Participants aged ≥65 years requiring ECG monitoring as part of routine care will be randomized to one of six ECG patch devices. The study aims to assess the proportion of analyzable ECG recordings and overall recording quality over a 7-day period.
Detailed description
Atrial fibrillation is a common arrhythmia often underdiagnosed due to its intermittent nature. Long-term ECG monitoring using wearable patch devices has emerged as an important diagnostic tool. However, comparative data between available devices are lacking. This randomized study compares six commercially available ECG patches regarding usability, adherence, and recording quality in an elderly outpatient population. Participants will independently apply the assigned device and undergo 7-day ECG monitoring. Device performance and patient feedback will be systematically assessed.
Interventions
DEVICESmartcardia 7L Patch
CE-certified multi-parameter ECG patch including additional physiological monitoring
DEVICEECG247
CE-certified ECG patch with smartphone-based data transmission.
DEVICEHeartX Recorder
CE-certified ECG patch designed for long-term continuous rhythm monitoring.
DEVICEKardiobeat
CE-certified multi-lead ECG patch for continuous cardiac monitoring
DEVICEnet_ECG
CE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring.
DEVICEZIO Patch
CE-certified single-lead ECG patch for long-term continuous rhythm monitoring
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an open-label study. Due to the nature of the interventions (different ECG patch devices with distinct designs and handling), blinding of participants, care providers, and investigators is not feasible.
Intervention model description
Participants are randomized in a 1:1:1:1:1:1 ratio to one of six ECG patch devices. Each participant receives one device for a 7-day monitoring period.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 65 years or older and residing in private homes * ECG patch intended for use as part of routine clinical practice * Written informed consent
Exclusion criteria
* Allergies to adhesive materials * Participation in another randomized trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with analyzable ECG recording ≥24 hours | 7 days | The proportion of participants who achieve at least 24 hours of analyzable ECG recording during the 7-day monitoring period. Analyzable ECG recording is defined as ECG data of sufficient technical quality to allow rhythm assessment, as determined by the certified analysis algorithm provided by the device manufacturer. Periods with insufficient signal quality (e.g., due to noise, signal loss, or artifacts) are excluded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of time with ECG recordings of sufficient quality | 7 days | The proportion of the total monitoring time (0-100%) during the 7-day period in which ECG recordings of sufficient quality are obtained. Sufficient quality is defined as ECG data that allow reliable rhythm interpretation, excluding periods with signal loss, noise, or artifacts. The proportion is calculated per participant as the percentage of total recorded time meeting these criteria. |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORMichael Schreinlechner, MD
Medical University Innsbruck
Outcome results
None listed