Heart MurmursKCI-1NCT07044128
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
An observational study of Heart Murmurs and Wheezing, run by Lapsi Health Holding B.V. at 1 site in Peru.
Trial summary
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app. The purpose of the study is to check how well this new device works and whether it is safe to use. Read more about this study
- Who is it for?
- Ages Up to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Murmurs, Wheezing
- What is being tested?
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Type of treatment
- Medical device
- How many people
- 149 participants
- Where
- 1 sitePeru
- Study dates
- 15 Jul 2025to 15 Oct 2025
- Phase
- Observational
- 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 Up to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will enroll 149 pediatric and adult male and non-pregnant female individuals, from birth to (and including) 99 years of age.
Who may be able to join
- Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.
- Individuals who are either:
- presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or for non-urgent cardiac clearance; or
- presenting for return, non-urgent outpatient evaluation of a cardiac murmur; or
- undergoing initial or recurrent, non-urgent evaluation of a cardiac murmur in inpatient setting; or
- undergoing non-urgent cardiac clearance in inpatient setting.
Who cannot join
- pregnant female individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app. The purpose of the study is to check how well this new device works and whether it is safe to use.
The study will include 149 participants of all ages (from birth to 99 years), who are undergoing routine (non-urgent) heart checks. After giving consent, each participant will have their heart sounds listened to twice: once with the Keikku electronic stethoscope and once with a regular stethoscope. Two different doctors will do the listening, and they won't share information with each other. The doctors will record whether they hear a heart murmur and how clear the sounds were.
Read more
The study will compare the findings from the new device to those from the regular stethoscope. Researchers will also check for any device problems or side effects. The study takes place at a single site in Peru and will take about one day for each participant.
The goal is to find out if the Keikku electronic stethoscope is accurate and safe for doctors to use in real medical settings.
Read the detailed description
This clinical study is designed to evaluate the performance and safety of the Keikku electronic stethoscope, an innovative medical device developed by Lapsi Health Holding BV. The Keikku device combines a micro-electromechanical system (MEMS) sensor with a Bluetooth-enabled smartphone application, allowing physicians to capture and review heart sounds in real-time or via secure cloud storage.
The Keikku electronic stethoscope differs from traditional stethoscopes in that it digitally records and transmits auscultation sounds without interpreting them. Physicians use the Keikku Mobile Application to listen, annotate, and share these sounds. This study assesses whether such a device can match the diagnostic capabilities of conventional analog stethoscopes, particularly in detecting heart murmurs.
This is a prospective, open-label, controlled clinical investigation involving 149 pediatric and adult participants (from birth to age 99) in non-urgent cardiac evaluations. Each participant undergoes two sequential heart sound assessments at four standard precordial chest locations (mitral, tricuspid, aortic, and pulmonary):
Keikku electronic stethoscope: used by a physician listening via Bluetooth headphones.
Conventional stethoscope: used by a second, blinded physician.
Each device's use is independently evaluated using predefined clinical report forms. Physicians record whether a murmur is present and rate the acoustic quality of the auscultation on a 5-point Likert scale.
To ensure objectivity, physicians do not communicate their findings, and the second physician has no access to the recordings or results obtained by the first. All recordings (both digital and analog) are stored on GDPR-compliant cloud servers. Final clinical decisions about patient care are based only on the findings of the conventional stethoscope, not the investigational device.
The study's primary endpoint is the agreement percentage between the Keikku and conventional stethoscopes in murmur detection. Secondary and exploratory endpoints include the incidence of device-related adverse events, the sensitivity and specificity of murmur detection, user-reported sound quality, and any technical issues (device deficiencies) encountered.
Participation in this study lasts only one day and involves no follow-up visits. No treatment decisions are made based on the investigational device. The research is conducted at a single site in Peru, and the data will contribute to a broader understanding of digital stethoscope performance in clinical environments.
By validating the diagnostic capabilities of the Keikku electronic stethoscope, this study aims to support the safe integration of digital auscultation technology into everyday clinical care and remote telemedicine applications.
- Conditions
- Heart Murmurs, Wheezing
- Being tested
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Keywords
- Stethoscopes, Heart Murmurs, Cardiac Auscultation, Diagnostic Techniques and Procedures, Medical Device Evaluation, Sound Recording and Reproduction, Pediatric Cardiology, Adult Cardiology, Telemedicine, Signal Processing, Computer-Assisted, Electronic Health Records, Clinical Accuracy, Safety Assessment, Prospective Studies
- Medical subject headings
- Heart Murmurs, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital stethoscope using MEMS sensor and mobile application for cardiac auscultationDevice
The intervention is a digital stethoscope system comprising a handheld device with a micro-electromechanical system (MEMS) sensor and a Bluetooth Low Energy (BLE) connection to a mobile application (Keikku Mobile App) installed on an iOS or Android smartphone. The device captures auscultation sounds from standard precordial locations (mitral, tricuspid, aortic, and pulmonary), transmits them in real time to the mobile application, and stores the recordings on a secure, GDPR-compliant cloud server. The device does not interpret sounds. Each auscultation lasts 15 seconds per site. Physicians use Bluetooth headphones to listen during recording. The application allows for annotation and review of sound data. The intervention is administered once per participant during a single study visit, immediately followed by a comparator auscultation using a conventional analog stethoscope by a second blinded physician.
| Study group | Role | What they receive |
|---|---|---|
| Keikku Stethoscope Evaluation Group - Pediatric | This group includes pediatric participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment. Receives: Device: Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation | |
| Keikku Stethoscope Evaluation Group - Adults | This group includes adult participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment. Receives: Device: Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in murmur detection between digital and conventional stethoscopes
Overall agreement (in percent) between the Keikku electronic stethoscope and a conventional analog stethoscope in identifying the presence or absence of a heart murmur.
Measured: Day 0 (Single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart MurmursStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lapsi Health Holding B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clínica Internacional
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044128
- Sponsor's protocol ID
- D087
- Acronym
- KCI-1
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope
- ClinicalTrials.gov ID
- NCT07044128
- Acronym / sponsor ID
- KCI-1 / D087
- Conditions
- Heart Murmurs, Wheezing
- Keywords
- Stethoscopes, Heart Murmurs, Cardiac Auscultation, Diagnostic Techniques and Procedures, Medical Device Evaluation, Sound Recording and Reproduction, Pediatric Cardiology, Adult Cardiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Lapsi Health Holding B.V.Industry (pharma, biotech, devices)
- Collaborators
- Clínica Internacional
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 29 Jun 2025 (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 study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app. The purpose of the study is to check how well this new device works and whether it is safe to use.
The study will include 149 participants of all ages (from birth to 99 years), who are undergoing routine (non-urgent) heart checks. After giving consent, each participant will have their heart sounds listened to twice: once with the Keikku electronic stethoscope and once with a regular stethoscope. Two different doctors will do the listening, and they won't share information with each other. The doctors will record whether they hear a heart murmur and how clear the sounds were.
The study will compare the findings from the new device to those from the regular stethoscope. Researchers will also check for any device problems or side effects. The study takes place at a single site in Peru and will take about one day for each participant.
The goal is to find out if the Keikku electronic stethoscope is accurate and safe for doctors to use in real medical settings.
Detailed description
This clinical study is designed to evaluate the performance and safety of the Keikku electronic stethoscope, an innovative medical device developed by Lapsi Health Holding BV. The Keikku device combines a micro-electromechanical system (MEMS) sensor with a Bluetooth-enabled smartphone application, allowing physicians to capture and review heart sounds in real-time or via secure cloud storage.
The Keikku electronic stethoscope differs from traditional stethoscopes in that it digitally records and transmits auscultation sounds without interpreting them. Physicians use the Keikku Mobile Application to listen, annotate, and share these sounds. This study assesses whether such a device can match the diagnostic capabilities of conventional analog stethoscopes, particularly in detecting heart murmurs.
This is a prospective, open-label, controlled clinical investigation involving 149 pediatric and adult participants (from birth to age 99) in non-urgent cardiac evaluations. Each participant undergoes two sequential heart sound assessments at four standard precordial chest locations (mitral, tricuspid, aortic, and pulmonary):
Keikku electronic stethoscope: used by a physician listening via Bluetooth headphones.
Conventional stethoscope: used by a second, blinded physician.
Each device's use is independently evaluated using predefined clinical report forms. Physicians record whether a murmur is present and rate the acoustic quality of the auscultation on a 5-point Likert scale.
To ensure objectivity, physicians do not communicate their findings, and the second physician has no access to the recordings or results obtained by the first. All recordings (both digital and analog) are stored on GDPR-compliant cloud servers. Final clinical decisions about patient care are based only on the findings of the conventional stethoscope, not the investigational device.
The study's primary endpoint is the agreement percentage between the Keikku and conventional stethoscopes in murmur detection. Secondary and exploratory endpoints include the incidence of device-related adverse events, the sensitivity and specificity of murmur detection, user-reported sound quality, and any technical issues (device deficiencies) encountered.
Participation in this study lasts only one day and involves no follow-up visits. No treatment decisions are made based on the investigational device. The research is conducted at a single site in Peru, and the data will contribute to a broader understanding of digital stethoscope performance in clinical environments.
By validating the diagnostic capabilities of the Keikku electronic stethoscope, this study aims to support the safe integration of digital auscultation technology into everyday clinical care and remote telemedicine applications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keikku Stethoscope Evaluation Group - Pediatric | – | Device: Digital stethoscope using MEMS sensor and mobile application for cardiac auscultationThis group includes pediatric participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment. |
| Keikku Stethoscope Evaluation Group - Adults | – | Device: Digital stethoscope using MEMS sensor and mobile application for cardiac auscultationThis group includes adult participants undergoing non-urgent cardiac evaluation. Each participant receives heart sound assessments using both the investigational Keikku electronic stethoscope and a conventional analog stethoscope. The primary aim is to compare the accuracy of murmur detection between the two devices. Evaluations are performed by two separate physicians to ensure independent assessment. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enroll 149 pediatric and adult male and non-pregnant female individuals, from birth to (and including) 99 years of age.
Key inclusion criteria (6 listed)
- Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.
- Individuals who are either:
Key exclusion criteria (1 listed)
- pregnant female individuals
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 |
|---|---|---|
| Digital stethoscope using MEMS sensor and mobile application for cardiac auscultationThe intervention is a digital stethoscope system comprising a handheld device with a micro-electromechanical system (MEMS) sensor and a Bluetooth Low Energy (BLE) connection to a mobile application (Keikku Mobile App) installed on an iOS or Android smartphone. The device captures auscultation sounds from standard precordial locations (mitral, tricuspid, aortic, and pulmonary), transmits them in real time to the mobile application, and stores the recordings on a secure, GDPR-compliant cloud server. The device does not interpret sounds. Each auscultation lasts 15 seconds per site. Physicians use Bluetooth headphones to listen during recording. The application allows for annotation and review of sound data. The intervention is administered once per participant during a single study visit, immediately followed by a comparator auscultation using a conventional analog stethoscope by a second blinded physician. | Device | Keikku Stethoscope Evaluation Group - Adults, Keikku Stethoscope Evaluation Group - Pediatric |
Primary outcome
Agreement in murmur detection between digital and conventional stethoscopes
Time frame: Day 0 (Single visit)
Overall agreement (in percent) between the Keikku electronic stethoscope and a conventional analog stethoscope in identifying the presence or absence of a heart murmur.
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 29 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Murmurs and Wheezing, run by Lapsi Health Holding B.V. at 1 site in Peru.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Jun 2025. 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 Peru. 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?
Contact Alfredo Gilberto Guerreros Benavides (+51 1 6196161, alfgb@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in murmur detection between digital and conventional stethoscopes (time frame: Day 0 (Single visit)). 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 29 Jun 2025.