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AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM - Trial NCT06378632

Access comprehensive clinical trial information for NCT06378632 through Pure Global AI's free database. This phase not specified trial is sponsored by Cordio Medical and is currently Recruiting. The study focuses on Heart Failure. Target enrollment is 500 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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ClinicalTrials.gov โ€ข NCT06378632
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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

Study Focus

Heart Failure

Hearo App

Observational

device

Sponsor & Location

Cordio Medical

Fairhope,La Jolla,Loma Linda,San Diego,San Francisco,San Francisco,Crystal River,Jacksonville,Miami,Miami,Miami,Plantation,Saint Augustine,Tampa,Carrollton,Chicago,Chicago,Downers Grove,Naperville,Wic, Israel,United States of America

Timeline & Enrollment

N/A

Feb 11, 2022

Dec 01, 2024

500 participants

Primary Outcome

Heart Failure Events (HFEs)

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.

ICD-10 Classifications

Heart failure
Heart failure, unspecified
Congestive heart failure
Hypertensive heart disease with (congestive) heart failure
Left ventricular failure

Data Source

ClinicalTrials.gov

NCT06378632

Device Trial