Comparison of 7-Day ECG Patches

Medical University Innsbruck

Status: Active, not recruiting

Conditions: Atrial Fibrillation (AF); Cardiac Arrhythmias

Treatments: Device: net_ECG; Device: ZIO Patch; Device: Kardiobeat; Device: ECG247; Device: HeartX Recorder; Device: Smartcardia 7L Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07564349

1133/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 6 patient groups

Smartcardia 7L Patch

Experimental group

Description:

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.

Treatment:

Device: Smartcardia 7L Patch

ECG247

Experimental group

Description:

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.

Treatment:

Device: ECG247

HeartX Recorder

Experimental group

Description:

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.

Treatment:

Device: HeartX Recorder

Kardiobeat

Experimental group

Description:

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.

Treatment:

Device: Kardiobeat

net_ECG

Experimental group

Description:

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.

Treatment:

Device: net_ECG

ZIO Patch

Experimental group

Description:

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.

Treatment:

Device: ZIO Patch