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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartcardia 7L Patch | Experimental | Participants randomized to this arm will receive the Smartcardia 7L ECG patch for a 7-day monitoring period and will apply the device independently according to instructions. |
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| ECG247 | Experimental | Participants randomized to this arm will receive the ECG247 ECG patch for a 7-day monitoring period and will apply the device independently according to instructions. |
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| HeartX Recorder | Experimental | Participants randomized to this arm will receive the HeartX Recorder for a 7-day monitoring period and will apply the device independently according to instructions. |
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| Kardiobeat | Experimental | Participants randomized to this arm will receive the Kardiobeat patch for a 7-day monitoring period and will apply the device independently according to instructions. |
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| net_ECG | Experimental | Participants randomized to this arm will receive the net_ECG patch for a 7-day monitoring period and will apply the device independently according to instructions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartcardia 7L Patch | Device | CE-certified multi-parameter ECG patch including additional physiological monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with analyzable ECG recording ≥24 hours | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative analysable ECG time | Cumulative duration, in hours, of analysable ECG obtained per participant during the intended 7-day monitoring period, where analysable ECG is defined as ECG of sufficient quality, according to the manufacturer's signal-quality criteria, to permit rhythm analysis. Participants without any recording were assigned a value of 0 hours. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Schreinlechner, MD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Innsbruck | 6020 | Austria |
De-identified individual participant data underlying the published results will be made available to researchers whose proposed use has been approved by an independent review committee, for analyses that have received appropriate ethics approval. Requesters will be asked to sign a data access agreement. Data are held in controlled-access storage at the Medical University of Innsbruck.
Beginning 6 months and ending 5 years after publication.
Proposals should be directed to the corresponding author. Access will be granted for approved analyses with appropriate ethics approval, after signing a data access agreement.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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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.
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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.
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| ZIO Patch | Experimental | Participants randomized to this arm will receive the ZIO Patch for a 7-day monitoring period and will apply the device independently according to instructions. |
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| ECG247 | Device | CE-certified ECG patch with smartphone-based data transmission. |
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| HeartX Recorder | Device | CE-certified ECG patch designed for long-term continuous rhythm monitoring. |
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| Kardiobeat | Device | CE-certified multi-lead ECG patch for continuous cardiac monitoring |
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| net_ECG | Device | CE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring. |
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| ZIO Patch | Device | CE-certified single-lead ECG patch for long-term continuous rhythm monitoring |
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