Atrial Fibrillation (AF)NCT07564349
Comparison of 7-Day ECG Patches
A study testing Smartcardia 7L Patch, ECG247 and HeartX Recorder in people with Atrial Fibrillation (AF) and Cardiac Arrhythmias, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiac Arrhythmias
- What is being tested?
- Smartcardia 7L Patch, ECG247 and HeartX Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 18 Sep 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older and residing in private homes
- ECG patch intended for use as part of routine clinical practice
- Written informed consent
Who cannot join
- Allergies to adhesive materials
- Participation in another randomized trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation (AF), Cardiac Arrhythmias
- Being tested
- Smartcardia 7L Patch, ECG247, HeartX Recorder, Kardiobeat, net_ECG
- Keywords
- ECG monitoring, wearable devices, atrial fibrillation screening, digital health, patch ECG, elderly population, ambulatory ECG monitoring
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartcardia 7L PatchDevice
CE-certified multi-parameter ECG patch including additional physiological monitoring
ECG247Device
CE-certified ECG patch with smartphone-based data transmission.
HeartX RecorderDevice
CE-certified ECG patch designed for long-term continuous rhythm monitoring.
KardiobeatDevice
CE-certified multi-lead ECG patch for continuous cardiac monitoring
net_ECGDevice
CE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring.
ZIO PatchDevice
CE-certified single-lead ECG patch for long-term continuous rhythm monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: ZIO Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start18 Sep 2025
- Primary completion1 May 2026
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Schreinlechner, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564349
- Sponsor's protocol ID
- 1133/2025
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Commercially Available 7-Day ECG Patches: A Randomized Study
- ClinicalTrials.gov ID
- NCT07564349
- Acronym / sponsor ID
- 1133/2025
- Conditions
- Atrial Fibrillation (AF), Cardiac Arrhythmias
- Keywords
- ECG monitoring, wearable devices, atrial fibrillation screening, digital health, patch ECG, elderly population, ambulatory ECG monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smartcardia 7L Patch | Experimental | Device: Smartcardia 7L PatchParticipants 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. |
| ECG247 | Experimental | Device: ECG247Participants 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. |
| HeartX Recorder | Experimental | Device: HeartX RecorderParticipants randomized to this arm will receive the HeartX Recorder for a 7-day monitoring period and will apply the device independently according to instructions. |
| Kardiobeat | Experimental | Device: KardiobeatParticipants randomized to this arm will receive the Kardiobeat patch for a 7-day monitoring period and will apply the device independently according to instructions. |
| net_ECG | Experimental | Device: net_ECGParticipants 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. |
| ZIO Patch | Experimental | Device: ZIO PatchParticipants randomized to this arm will receive the ZIO Patch for a 7-day monitoring period and will apply the device independently according to instructions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years or older and residing in private homes
- ECG patch intended for use as part of routine clinical practice
- Written informed consent
Key exclusion criteria (2 listed)
- Allergies to adhesive materials
- Participation in another randomized trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartcardia 7L PatchCE-certified multi-parameter ECG patch including additional physiological monitoring | Device | Smartcardia 7L Patch |
| ECG247CE-certified ECG patch with smartphone-based data transmission. | Device | ECG247 |
| HeartX RecorderCE-certified ECG patch designed for long-term continuous rhythm monitoring. | Device | HeartX Recorder |
| KardiobeatCE-certified multi-lead ECG patch for continuous cardiac monitoring | Device | Kardiobeat |
| net_ECGCE-certified 3 lead ECG patch designed for long-term continuous rhythm monitoring. | Device | net_ECG |
| ZIO PatchCE-certified single-lead ECG patch for long-term continuous rhythm monitoring | Device | ZIO Patch |
Primary outcome
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.
1 secondary outcome
Cumulative analysable ECG time
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schreinlechner, MD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartcardia 7L Patch, ECG247 and HeartX Recorder in people with Atrial Fibrillation (AF) and Cardiac Arrhythmias, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with analyzable ECG recording ≥24 hours (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.