Comparison of 7-Day ECG Patches

April 27, 2026 updated by: Medical University Innsbruck

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartcardia 7L Patch
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.
Device: Smartcardia 7L Patch
CE-certified multi-parameter ECG patch including additional physiological monitoring
Experimental: ECG247
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.
Device: ECG247
CE-certified ECG patch with smartphone-based data transmission.
Experimental: HeartX Recorder
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.
Device: HeartX Recorder
CE-certified ECG patch designed for long-term continuous rhythm monitoring.
Experimental: Kardiobeat
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.
Device: Kardiobeat
CE-certified multi-lead ECG patch for continuous cardiac monitoring
Experimental: net_ECG
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.
Device: net_ECG
CE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring.
Experimental: ZIO Patch
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.
Device: ZIO Patch
CE-certified single-lead ECG patch for long-term continuous rhythm monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time with ECG recordings of sufficient quality
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Michael Schreinlechner, MD, Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1133/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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