Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378632
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-14
Brief Title:
AN INTERNATIONAL OBSERVATIONAL BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
Sponsor:
Cordio Medical
Organization:
Cordio Medical
Study Overview
Official Title:
An International Multi-center Observational Single-arm Blinded Study to Assess the Performance of the Cordio HearO System
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT-HF
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None