eWave Patch for Heart Monitoring

AB
CD
Overseen ByChris Daniel
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wearlinq
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the ease of use of the WearLinq eWave patch, a device that monitors heart activity. Participants will wear the patch for either 7 or 30 days to assess its effectiveness. This trial may suit adults who can use a smartphone app and have no skin allergies or electronic implants like pacemakers. As an unphased trial, it provides a unique opportunity to contribute to the development of innovative heart monitoring technology.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the eWave Patch is safe for heart monitoring?

Studies have shown that the eWave Patch is safe for use. This wearable heart monitor has received FDA approval, meeting safety standards for checking heart activity. This approval confirms that the patch is safe and unlikely to cause harm. The eWave Patch uses six sensors to offer a detailed view of heart activity, aiding in the detection of heart issues without causing discomfort. In summary, research suggests that the eWave Patch is safe and easy to use for heart monitoring.12345

Why are researchers excited about this trial?

The eWave Patch is unique because it offers a non-invasive way to continuously monitor heart activity using a wearable patch. Unlike traditional heart monitoring systems that can be bulky and uncomfortable, this patch is designed to be lightweight and easy to wear, allowing for more natural daily activities. Researchers are excited about the potential of the eWave Patch to provide real-time, detailed cardiac data over an extended period—up to 30 days—without the need for frequent hospital visits. This could lead to earlier detection of heart issues and more personalized treatment plans.

What evidence suggests that the eWave Patch is effective for heart monitoring?

Research shows that the eWave Patch provides a detailed view of the heart using six different sensors, surpassing the usual single-sensor patches that can miss some heart events. In this trial, participants will apply the WearLinq patch for either 7 or 30 consecutive days, depending on their assigned study arm. Studies indicate that wearable heart monitors like the eWave can perform as effectively as the traditional 24-hour Holter monitor in tracking heart activity over longer periods. This capability helps doctors detect infrequent heart issues. The eWave's clear heart readings make it a valuable tool for monitoring heart health.12467

Who Is on the Research Team?

CD

Chris Daniel

Principal Investigator

WearLinq, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and use a smartphone app. They must be willing to shave the area where the eWave patch will be placed if necessary. It's not for those with allergies to adhesives, skin conditions affecting the chest, electronic implants like pacemakers, or pregnant individuals.

Inclusion Criteria

I am over 18 and can give my consent.
Capable of using a smartphone app
I am willing to shave the area where the patch will be applied if necessary.

Exclusion Criteria

Planning to undergo an MRI during the study period
Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies, or any other dermatological condition that could confound placement or results
I do not have open wounds or infections on my chest where a device might be placed.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive and apply the WearLinq patch for 7 consecutive days

1 week

Extended Use

A subset of participants will continue to use the WearLinq patch for 30 consecutive days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • eWave Patch

Trial Overview

The study tests how easy it is for people to use the WearLinq eWave patch, which monitors heart activity through ECG readings. Participants will wear this device and interact with its accompanying smartphone app.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Extended Use CohortExperimental Treatment1 Intervention
Group II: 7 Day StudyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wearlinq

Lead Sponsor

ABio Clinical Research Partners

Collaborator

Citations

A Usability Study of a Multi-channel ECG Monitoring Device

Study Overview. Brief Summary. This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.

2.

wearlinq.com

wearlinq.com/

Wearlinq Labs - Elevating the Standard of Cardiac Monitoring

As a cardiac monitor with 6 distinct leads, the eWave provides cardiologists with a detailed multidimensional view of the heart with exceptional ECG clarity.

Wearable ECG patch monitoring for 72 h is comparable ... - PMC

We sought to compare the diagnostic efficacy of a 72-hour wearable electrocardiography (ECG) patch monitoring with a conventional 24-hour Holter monitoring for ...

Noninvasive Hemodynamic Assessment by a Sensor Patch

The purpose of this study was to evaluate a multimodal sensor patch's (SANSA) assessment of DFT, pre-ejection period (PEP), and left ventricular ejection time ...

Why Cardiologists Are Betting $19M on Wearlinq to Fix ...

Single-Lead Patches: Easy to wear but provide a limited “view” of the heart, often missing intermittent events or subtle electrical changes.

WearLinq to expand access to FDA-cleared wearable ECG

eWave, a 6-lead wearable ECG monitor, recently received FDA 510(k) clearance. San Francisco-based WearLinq's acquisition also comes on the heels ...

7.

firstwordhealthtech.com

firstwordhealthtech.com/story/6773954

Wearlinq raises $14M to bring remote heart monitoring ...

Overcoming the limitations of previous monitoring technologies, eWave is capable of "transforming continuous cardiac signals into actionable ...