Eko Sensora Device for Heart Murmurs

(EkoNM Trial)

Overseen By Monique Luna, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Spectrum Health - Lakeland

Disqualifiers: Contact isolation, Pediatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Eko Sensora treatment for heart murmurs?

The research on accelerometer-type cardiac transducers shows that these devices can effectively detect low-level heart sounds, which are important for identifying heart murmurs. Additionally, wearable ECG systems have been shown to improve diagnosis accuracy for heart conditions, suggesting that similar technology in the Eko Sensora could be effective for detecting heart murmurs. ^{1 2 3 4 5}

Is the Eko Sensora Device for Heart Murmurs safe for human use?

There is no specific safety data available for the Eko Sensora Device for Heart Murmurs in the provided research articles. ^{1 6 7 8 9}

How does the Eko Sensora Device for Heart Murmurs differ from other treatments?

The Eko Sensora Device is unique because it likely integrates advanced ECG monitoring with wearable technology, allowing for continuous and context-aware monitoring of heart activity. This approach is more convenient and potentially more accurate than traditional methods, as it can be used in everyday settings without the need for bulky equipment. ^{1 2 6 10 11}

What is the purpose of this trial?

The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023). The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction. The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.

Eligibility Criteria

This trial is for people over 50 with symptoms like chest pain or shortness of breath, and a history of conditions such as high blood pressure, obesity, diabetes, heart issues or stroke. It's not for those in isolation or under 18.

Inclusion Criteria

Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/TIA, prior cardiac surgery or angiography

Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.

Exclusion Criteria

Pediatric patients under the age of 18

Contact isolation patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

The Eko SENSORA device is tested in the emergency department to detect clinically significant murmurs

4-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• Eko Sensora

Trial Overview The Eko Sensora device is being tested to see if it can detect serious heart valve disease by recording heart sounds using AI technology in an emergency department setting.

Participant Groups

Group I: Eko Device Experimental Treatment 1 Intervention

Patients with cardiac risk factors

Who Is Running the Clinical Trial?

Spectrum Health - Lakeland

Lead Sponsor

Trials

14

Recruited

1,300+

Findings from Research

The proposed wearable ECG monitoring system is compact and energy-efficient, measuring only 58 × 50 × 10 mm and consuming just 12.5 mW during ECG acquisition, making it convenient for long-term use.

By integrating smartphone kinetic sensors, the system enhances diagnosis accuracy for arrhythmias and identifies abnormal ECG patterns based on the user's physical activity, providing context-aware monitoring without additional costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Context-Aware ECG Monitoring System Integrated with Built-in Kinematic Sensors of the Smartphone. Miao, F., Cheng, Y., He, Y., et al.[2018]

The intelligent Personal ECG Monitor developed by the European EPI-MEDICS project offers a cost-effective solution for early detection of cardiac events, improving decision-making without the need for extensive infrastructure.

This device integrates with electronic health records and uses advanced communication to alert care providers only when necessary, making healthcare more personalized and accessible, especially for the growing elderly population at risk for heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pervasive self-care solutions in telecardiology. Typical use cases from the EPI-MEDICS project. Gouaux, F., Chautemps, LS., Fayn, J., et al.[2007]

Wearable devices can significantly aid heart failure care by monitoring vital signs like movement, heart rate, and blood pressure, as well as detecting arrhythmias, which can enhance patient management and rehabilitation.

Despite their potential, the integration of wearable technology into clinical practice is slow due to concerns about data security, validity, and regulatory issues, highlighting the need for more research to demonstrate their meaningful impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Wearables in Heart Failure. Singhal, A., Cowie, MR.[2021]

The study introduces a highly sensitive accelerometer that can continuously monitor lung and heart sounds, achieving a sensitivity of 9.2 V/g at frequencies below 1000 Hz, making it effective for detecting weak physiological signals in pneumonia patients.

This sensor successfully identified lung and heart injuries in discharged pneumonia patients and tracked their recovery, demonstrating its potential as a cost-effective tool for both clinical and home health monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-stage amplified PZT sensor for monitoring lung and heart sounds in discharged pneumonia patients. Chen, H., Yu, S., Liu, H., et al.[2021]

The development of a low-mass accelerometer cardiac transducer, weighing only 5 g, achieves high sensitivity (125 mV/g) and operates effectively in the frequency range of 200-800 Hz, making it suitable for advanced phonocardiography applications.

This transducer has successfully detected sounds related to turbulent blood flow in partially occluded coronary arteries, indicating its potential for improving cardiac diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerometer type cardiac transducer for detection of low-level heart sounds. Padmanabhan, V., Semmlow, JL., Welkowitz, W.[2010]

The KC-02 indicator is designed for continuous monitoring of cardiac activity by analyzing rhythm patterns from ECG recordings, which can help in early detection of heart issues.

This system emphasizes the importance of careful design principles to ensure accurate and reliable readings of electrocardiosignals, enhancing patient safety and monitoring efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[KS-02 cardiosignal indicator]. Bol'shov, VM., Popov, VP., Prokudin, AS., et al.[2006]

Out of 16 health-monitoring devices tested, only four met the accuracy requirements for clinical use, highlighting concerns about the reliability of consumer-marketed devices.

The AliveCor ECG monitor was notably accurate, detecting heart rates correctly 87% of the time, while other devices like the Withings Pulse Ox and Tinké showed limitations in their alternative functions, indicating that caution is needed when using these devices for medical purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Commercially Marketed Health Devices for Potential Clinical Application. Uchimura, KD., Adamson, TL., Karaniuk, KM., et al.[2020]

The CardioGuard system, a brassiere-based ECG monitoring sensor, reliably detects heart activity during various daily activities, achieving an average detection rate of 89.53% for QRS peaks.

User feedback from a study with 15 participants indicated that the CardioGuard sensor is comfortable and unobtrusive, highlighting its potential for everyday use in smartphone healthcare applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CardioGuard: a brassiere-based reliable ECG monitoring sensor system for supporting daily smartphone healthcare applications. Kwon, S., Kim, J., Kang, S., et al.[2018]

Capacitive electrodes for ECG measurement offer a non-contact method that reduces noise and improves the quality of heart signal readings, making them suitable for daily life applications.

Ongoing research aims to enhance the usability of these electrodes, potentially expanding their use in wearable technology and other healthcare applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capacitive measurement of ECG for ubiquitous healthcare. Lim, YG., Lee, JS., Lee, SM., et al.[2014]

A new battery-less and flexible chest patch device can monitor important cardiac and hemodynamic parameters, including ECG, sweat pH, and skin temperature, by using a smartphone for data acquisition in just about 5 seconds.

This innovative device operates with low power consumption (1.8 mW) and provides sensitive measurements, making it suitable for fast screening in both emergency and home monitoring scenarios for individuals with cardiac-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NFC-Powered Flexible Chest Patch for Fast Assessment of Cardiac, Hemodynamic, and Endocrine Parameters. Rosa, BMG., Anastasova-Ivanova, S., Yang, GZ.[2020]

The proposed ultra-low power ECG sensor is compact and consumes only 1 mW, allowing for continuous 24-hour monitoring of ECG signals during daily activities, making it a practical wearable health monitor.

While the ECG sensor's performance is slightly lower than that of a conventional Holter device, it still provides good quality ECG signals and arrhythmia detection accuracy, confirming its feasibility for long-term health monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ultra-low power (ULP) bandage-type ECG sensor for efficient cardiac disease management. Shin, K., Park, GG., Kim, JP., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Wearable Context-Aware ECG Monitoring System Integrated with Built-in Kinematic Sensors of the Smartphone. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Pervasive self-care solutions in telecardiology. Typical use cases from the EPI-MEDICS project. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Wearables in Heart Failure. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A two-stage amplified PZT sensor for monitoring lung and heart sounds in discharged pneumonia patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Accelerometer type cardiac transducer for detection of low-level heart sounds. [2010]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[KS-02 cardiosignal indicator]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Commercially Marketed Health Devices for Potential Clinical Application. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

CardioGuard: a brassiere-based reliable ECG monitoring sensor system for supporting daily smartphone healthcare applications. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Capacitive measurement of ECG for ubiquitous healthcare. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

NFC-Powered Flexible Chest Patch for Fast Assessment of Cardiac, Hemodynamic, and Endocrine Parameters. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

An ultra-low power (ULP) bandage-type ECG sensor for efficient cardiac disease management. [2020]