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NCT06378632Recruiting

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
Cordio MedicalClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Heart Failure
Drug/Device/Intervention
Hearo App
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Cordio Medical
Location
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
Phase
N/A
Start date
Feb 11, 2022
End date
Dec 01, 2024
Enrollment
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 failureHeart failure, unspecifiedCongestive heart failureHypertensive heart disease with (congestive) heart failureLeft ventricular failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06378632
Type
Device Trial
About this record

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.