Comparison of 7-Day ECG Patches

NCT07564349 | Active Not Recruiting

• 1 other identifier: 1133/2025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF); Cardiac Arrhythmias

Keywords

ECG monitoring; wearable devices; atrial fibrillation screening; digital health; patch ECG; elderly population; ambulatory ECG monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Proportion of time with ECG recordings of sufficient quality

  7 days

Study Arms (6)

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.

Device: Smartcardia 7L Patch

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.

Device: ECG247

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.

Device: HeartX Recorder

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.

Device: Kardiobeat

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.

Device: net_ECG

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.

Device: ZIO Patch

Interventions

Smartcardia 7L Patch DEVICE

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

Smartcardia 7L Patch

ECG247 DEVICE

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

ECG247

HeartX Recorder DEVICE

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

HeartX Recorder

Kardiobeat DEVICE

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

Kardiobeat

net_ECG DEVICE

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

net_ECG

ZIO Patch DEVICE

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

ZIO Patch

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older and residing in private homes
• ECG patch intended for use as part of routine clinical practice
• Written informed consent

You may not qualify if:

• Allergies to adhesive materials
• Participation in another randomized trial

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Michael Schreinlechner, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: September 18, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

AU (1)