Prospective, Controlled, Open-label Study Evaluating the Keikku Electronic Stethoscope

What this Trial Is About

Researchers are evaluating the Keikku electronic stethoscope, a digital device that records heart sounds using a smartphone app, in comparison to the traditional analog stethoscope. The study includes 149 participants ranging from newborns to adults up to 99 years old who are undergoing routine, non-urgent heart evaluations. The purpose is to assess how well the new device works and whether it is safe to use in clinical settings. Participants receive two heart sound assessments during a single visit: one with the Keikku electronic stethoscope and one with a conventional stethoscope. Two different doctors perform these assessments independently without sharing information. The Keikku device uses a MEMS sensor and transmits sounds via Bluetooth to a mobile app, allowing real-time listening and recording, while the conventional stethoscope is used by the second physician in a standard manner. Each participant's heart sounds are assessed at four chest locations, with doctors noting the presence of heart murmurs and rating sound quality. All recordings are securely stored on cloud servers. The main outcome measured is the agreement between the two devices in detecting murmurs. Researchers also monitor any device-related issues or side effects. The entire study takes about one day per participant, with no follow-up visits, focusing on understanding the device's accuracy and safety for future medical use and telemedicine.

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