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

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Hearo App — DEVICE
  No intervention - only data collection

Study Details

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.

Key Dates

Start date

Feb 11, 2022

Status verified

Mar 2025

Primary completion

Jul 1, 2025

Completion

Jul 15, 2025

Study Design

Enrollment

500 participants (estimated)

Primary Outcome Measure

Heart Failure Events (HFEs) [ Time Frame: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient ]

Central Contacts

• Bill Tobin
  (203) 852-8900
  [email protected]

Locations (37)

Find similar trials in Fairhope, AL

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