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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital stethoscope, the Eko Sensora, in emergency rooms. The device uses AI to listen to heart sounds and detect issues like valvular heart disease, which affects the heart valves. It aims to catch these problems early in patients with symptoms such as chest pain, fatigue, or shortness of breath. Individuals experiencing chest pain, difficulty breathing, or episodes of fainting might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how this new technology works in people, offering participants the chance to be among the first to benefit from innovative heart health solutions.

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 prior data suggests that the Eko Sensora device is safe for detecting heart murmurs?

Research shows that the Eko Sensora device, which uses artificial intelligence (AI) to detect heart murmurs, is still undergoing safety testing in people. As this is an early-stage trial, limited information exists about how well people tolerate the device. However, earlier AI technology from Eko has already received FDA approval for detecting heart problems during regular doctor visits, indicating that the technology has passed some safety checks.

Although specific safety data for the Eko Sensora is not yet available, the device is non-invasive, meaning it doesn't involve surgery or medication, which typically reduces risks. Currently, as the trial remains in its early phase, researchers continue to learn about any possible side effects or issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Eko Sensora device is unique because it uses advanced digital stethoscope technology to detect heart murmurs more accurately than traditional methods. Unlike standard stethoscopes, which rely on a healthcare provider's skill and experience to identify abnormal heart sounds, the Eko Sensora is equipped with artificial intelligence that enhances diagnostic precision. This feature not only aids in early detection but also reduces the risk of missed or misdiagnosed heart conditions, making it a promising tool for managing cardiac risk factors. Researchers are excited about this device because it could transform how heart murmurs are detected, offering a more reliable and efficient solution compared to existing options.

What evidence suggests that the Eko Sensora device is effective for detecting heart murmurs?

Research has shown that the Eko Sensora device, used by participants in this trial, employs artificial intelligence (AI) and a digital stethoscope to effectively detect heart murmurs. The AI technology is more than twice as sensitive in identifying heart valve issues related to murmurs compared to traditional methods. Specifically, studies have demonstrated that the device can quickly distinguish between harmless and serious heart murmurs in less than a minute. This early detection could lead to better treatment for heart issues. Although primarily tested in regular doctor's offices, the device also shows promise for use in emergency settings to identify significant heart problems. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. ekohealth.com ekohealth.com/pages/sensora?srsltid=AfmBOorAShksPMUthkg2wGZv6W3klhauYgj050mROTrUx4IjiWZEIiZj

SENSORA™ Detection Platform SENSORA™ is Eko's enterprise-level cardiac disease detection platform that combines ECG data and heart sound analysis to help providers achieve earlier and ...

2. ekohealth.com ekohealth.com/blogs/eko-blog/understanding-structural-heart-murmurs?srsltid=AfmBOoq7LEW6xaNgH3stmuehiEo8tI9V1Cg3VRWifr7doZUHCXwfgJTH

Understanding Structural Heart Murmurs The FDA-cleared suite of algorithms can distinguish between innocent and structural murmurs via smart stethoscopes in less than a minute.1.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05176899

Real-World Evaluation of Eko Murmur Analysis Software in ... Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence ...

4. withpower.com withpower.com/trial/early-phase-1-heart-murmurs-9-2023-76089

Eko Sensora Device for Heart Murmurs (EkoNM Trial) 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 ...

5. ekohealth.com ekohealth.com/blogs/newsroom/breakthrough-clinical-data-eko-health-s-ai-significantly-improves-heart-disease-detection-in-primary-care?srsltid=AfmBOoopYFndlfvqTNETRvti0R16R5gq1ycjCaIVbAjxs7vAKTAdeslk

Data Demonstrates Clinical Efficacy of SENSORA™ Platform The study found that the AI method showed over two times improvement in the detection sensitivity of VHD associated with a murmur. The AI method ...

6. ekohealth.com ekohealth.com/pages/sensora?srsltid=AfmBOoq4zkWxEFW1yxPrMvBTsZ9h-wsDSTdy8EYDTMV77NxOfO_tmxBp

SENSORA™ Detection Platform SENSORA™ is Eko's enterprise-level cardiac disease detection platform that combines ECG data and heart sound analysis to help providers achieve earlier and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06155643

EKO SENSORA: Detecting Clinically Significant Murmurs The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are ...

8. ekohealth.com ekohealth.com/blogs/newsroom/eko-launches-sensora?srsltid=AfmBOopM9E6Xrhw9oGt1ZX-Kt1UN0ncVVVm1AAzuquvEkeXtSyithpcJ

Eko Launches SENSORA™ Cardiac Disease Detection ... SENSORA™ currently features AI that objectively identifies structural murmurs, a sign of valvular heart disease, and Care Pathway Analytics ...

9. patientcareonline.com patientcareonline.com/view/fda-clears-first-ai-based-algorithm-to-detect-heart-failure-during-routine-exams

FDA Clears First AI-Based Algorithm to Detect Heart ... The Low EF AI is designed to detect low ejection fraction in 15 seconds during a primary care exam.