International Observational Study to Evaluate the Cordio HearO System in Adults with Symptomatic Chronic Heart Failure

What this Trial Is About

Researchers are conducting an international, multicenter, observational study to assess the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. This non-interventional, prospective, single-arm study aims to collect patient voice recordings to analyze the sensitivity and unique patient noise reduction UPNR capabilities of the HearO device. The study is sponsored by Cordio Medical and focuses on monitoring heart failure events over time. The study consists of two periods a Run-In period where patients submit daily recordings to establish a baseline, followed by a Core period where patients continue daily submissions for up to 24 months or until the study ends. There is no active treatment or intervention beyond data collection using the HearO app, which records patient utterances for later analysis. Participants will submit daily voice recordings throughout the study duration. Researchers will monitor heart failure events, defined as first usable and adjudicated heart failure events, as the primary outcome. The study involves regular data collection without additional interventions, focusing on patient adherence to daily use of the app. The total observation period per participant may last up to 24 months or until a predefined number of heart failure events have occurred.

AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM