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

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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.

Beobachtend500 Teilnehmende gesucht45 Studienzentren3 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT06378632Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

Zusammenfassung

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.

Erkrankungen

Heart Failure

Eignung

Eignung
Geschlecht	Alle
Alter	22 Years – Kein Höchstalter
Gesunde Freiwillige	Nein
Stichprobenverfahren	NON_PROBABILITY_SAMPLE

Studienpopulation

Outpatient clinics

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Beobachtend
Phase	Im Registereintrag nicht angegeben
Zuteilung	Im Registereintrag nicht angegeben
Interventionsmodell	Im Registereintrag nicht angegeben
Primäres Ziel	Im Registereintrag nicht angegeben
Verblindung	Im Registereintrag nicht angegeben
Teilnahme	500 Teilnehmende gesucht

Sponsor und Mitwirkende

Cordio Medical Sponsor

Interventionen

Medizinprodukt Hearo App
No intervention - only data collection

Endpunkte

Primärer Endpunkt
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
Zeitrahmen 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

Daten

Daten
Startdatum	11. Februar 2022 (tatsächlich)
Primärer Abschluss	1. Juli 2025 (geschätzt)
Abschluss	15. Juli 2025 (geschätzt)
Erstveröffentlichung	22. April 2024 (tatsächlich)
Zuletzt aktualisiert	26. März 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	März 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

45 Studienzentren rekrutieren

Israel

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

Spain

Spain
Einrichtung	Stadt	Bundesland oder Region	Status
Hospital Universitari Germans Trias i Pujol	Badalona		Rekrutiert

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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