NCT06378632ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

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.

Observational500 participants sought45 sites3 countries

Registered in 1 registry

ClinicalTrials.govNCT06378632Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 801 days after the recorded start)First posted 2024-04-22; recorded start 2022-02-11
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: Whether there is a comparison group is not stated in the registry recordThe record does not describe the study arms
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Cordio Medical)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type7/10
Clinical-event endpoint
Multi-centre8/8
Multi-centre: 45 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration0/5
Registered more than 30 days after the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 500 participants (target), run at 45 sites, across 3 countries.

How this score is built

Enrolment26/40
500 participants (target)
Site count19/25
45 sites
Country count7/15
3 countries
Planned duration8/10
Planned over about 42 months
Sponsor scale1/10
Cordio Medical has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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

Eligibility

Eligibility
Sex	All
Ages	22 Years – No maximum
Healthy volunteers	No
Sampling method	NON_PROBABILITY_SAMPLE

Study population

Outpatient clinics

Eligibility as written in the registry

Major Inclusion Criteria: 1. Age 22 or greater 2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\] 3. At least one of the following: 1. One ADHF hospitalization in the last 12 months 2. One unplanned IV/SC diuretic administration in the last 6 months 3. Two unplanned IV/SC diuretic administrations in the last 12 months 4. NTProBNP \>500 pg/ml 4. Clinically stable HF according to investigator discretion 5. Willing to participate as evidenced by signing the written informed consent. Major Exclusion Criteria: 1. Unable to comply with daily use of the App, 2. Has had a major cardiovascular event within 3 months prior to enrolment. 3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit. 4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73. 5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit. 6. Was treated for a significant COPD

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Observational
Phase	Not stated in the registry record
Allocation	Not stated in the registry record
Intervention model	Not stated in the registry record
Primary purpose	Not stated in the registry record
Masking	Not stated in the registry record
Enrolment	500 participants sought

Sponsor and collaborators

Cordio Medical Sponsor

Interventions

Device Hearo App
No intervention - only data collection

Outcome measures

Primary outcome
Heart Failure Events (HFEs)
Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period
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

Dates

Dates
Start date	February 11, 2022 (actual)
Primary completion	July 1, 2025 (estimated)
Completion	July 15, 2025 (estimated)
First posted	April 22, 2024 (actual)
Last updated	March 26, 2025
Results posted	Not stated in the registry record
Status last verified	March 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

45 sites are recruiting

Israel

Israel
Facility	City	Status
University Hospital Samson Assuta Ashdod	Ashdod	Recruiting
Assuta Be'er Sheva Medical Center	Beersheba	Recruiting
Rambam Medical Center	Haifa	Recruiting
Shaare Zedek Medical Center	Jerusalem	Recruiting
Galiee Medical Center	Nahariya	Recruiting
Tel Aviv Sourasky (Ichilov) Medical Center	Tel Aviv	Recruiting
Poriya Medical Center	Tiberias	Recruiting

Spain

Spain
Facility	City	State or region	Status
Hospital Universitari Germans Trias i Pujol	Badalona		Recruiting

United States

United States
Facility	City	State or region	Status
Mission Hospital	Asheville	North Carolina	Recruiting
West Georgia Cardiology	Carrollton	Georgia	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
Advocate Illinois Masonic Medical Center	Chicago	Illinois	Recruiting
The Lindner Research Center at The Christ Hospital	Cincinnati	Ohio	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
The Ohio State University	Columbus	Ohio	Recruiting
Nature Coast Clinical Research	Crystal River	Florida	Recruiting
Advocate Illinois Masonic Health Center	Downers Grove	Illinois	Recruiting
St. Elizabeth Healthcare	Edgewood	Kentucky	Recruiting
Eastern Shore Research Institute	Fairhope	Alabama	Recruiting
Moses H. Cone Memorial Hospital	Greensboro	North Carolina	Recruiting
Cardiovascular Institute of the South	Houma	Louisiana	Recruiting
Jacksonville Center for Clinical Research	Jacksonville	Florida	Recruiting
UC San Diego Health	La Jolla	California	Recruiting
Cardiovascular Institute of the South	Lafayette	Louisiana	Recruiting
Nebraska Heart Center	Lincoln	Nebraska	Recruiting
VA Loma Linda Healthcare System	Loma Linda	California	Recruiting
Rio Grande Regional Hospital	McAllen	Texas	Recruiting
Baptist Health (Miami Cardiac & Vascular Institute)	Miami	Florida	Recruiting
Advance Medical Research Services Corp (AMRS)	Miami	Florida	Recruiting
Amavita Clinical Research	Miami	Florida	Recruiting
Midwest Cardiovascular Center	Naperville	Illinois	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
University Medical Center New Orleans	New Orleans	Louisiana	Recruiting
Mount Sinai Morningside	New York	New York	Recruiting
The Mount Sinai Hospital	New York	New York	Recruiting
VA Southern Nevada Healthcare System	North Las Vegas	Nevada	Recruiting
Comprehensive Medical & Research Center	Plantation	Florida	Recruiting
St. Francis Hospital	Roslyn	New York	Recruiting
St. Johns Center for Clinical Research	Saint Augustine	Florida	Recruiting
Methodist Hospital of San Antonio	San Antonio	Texas	Recruiting
VA San Diego	San Diego	California	Recruiting
Kaiser Permanente San Francisco	San Francisco	California	Recruiting
University of California, San Francisco	San Francisco	California	Recruiting
Tampa General Hospital	Tampa	Florida	Recruiting
Robert J. Dole VA Medical Center	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06378632

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Study population

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Interventions

Outcome measures

Dates

Locations

Israel

Spain

United States

Study documents

Changes over time