Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.

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.

NCT Number	NCT07044128
Lead Sponsor	Lapsi Health Holding B.V. Collaborators: Clínica Internacional
Conditions	Heart Murmurs, Wheezing
Enrollment	149 participants
Start Date	2025-07-15
Primary Completion	2025-09-15 (estimated)
Study Completion	2025-10-15 (estimated)
Updated on ClinicalTrials.gov	2025-06-29