NCT06378632

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

An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cordio Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Detailed description

Two periods: Run-In period will be a period in which patients will submit daily recordings, baseline creation Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Hearo App	No intervention - only data collection

Timeline

• Start date: 2022-02-11
• Primary completion: 2025-07-01
• Completion: 2025-07-15
• First posted: 2024-04-22
• Last updated: 2025-03-26

Locations

45 sites across 3 countries: United States, Israel, Spain

Regulatory

• FDA-regulated device study