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Active, Not Recruiting

NCT Number: NCT07564349

Comparison of 7-Day ECG Patches

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiac Arrhythmias Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck

Innsbruck, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartcardia 7L Patch

Device

CE-certified multi-parameter ECG patch including additional physiological monitoring

ECG247

Device

CE-certified ECG patch with smartphone-based data transmission.

HeartX Recorder

Device

CE-certified ECG patch designed for long-term continuous rhythm monitoring.

Kardiobeat

Device

CE-certified multi-lead ECG patch for continuous cardiac monitoring

net_ECG

Device

CE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring.

Zio Patch

Device

CE-certified single-lead ECG patch for long-term continuous rhythm monitoring

Primary outcomes

  1. Proportion of participants with analyzable ECG recording ≥24 hours

    Time frame: 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 outcomes

  1. Cumulative analysable ECG time

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Comparison of Commercially Available 7-Day ECG Patches: A Randomized Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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