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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

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.

Observationnelle500 participants recherchés45 sites3 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06378632Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

Heart Failure

Éligibilité

Éligibilité
Sexe	Tous
Âges	22 Years – Aucun maximum
Volontaires sains	Non
Méthode d'échantillonnage	NON_PROBABILITY_SAMPLE

Population de l'étude

Outpatient clinics

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Observationnelle
Phase	Non précisé dans la fiche du registre
Répartition	Non précisé dans la fiche du registre
Modèle d'intervention	Non précisé dans la fiche du registre
Objectif principal	Non précisé dans la fiche du registre
Insu	Non précisé dans la fiche du registre
Recrutement	500 participants recherchés

Promoteur et collaborateurs

Cordio Medical Promoteur

Interventions

Dispositif Hearo App
No intervention - only data collection

Critères de jugement

Critère de jugement principal
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
Délai 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
Date de début	11 février 2022 (réelle)
Achèvement principal	1 juillet 2025 (estimée)
Achèvement	15 juillet 2025 (estimée)
Première publication	22 avril 2024 (réelle)
Dernière mise à jour	26 mars 2025
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	mars 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

45 sites sont en recrutement

Israel

Israel
Établissement	Ville	Statut
University Hospital Samson Assuta Ashdod	Ashdod	En recrutement
Assuta Be'er Sheva Medical Center	Beersheba	En recrutement
Rambam Medical Center	Haifa	En recrutement
Shaare Zedek Medical Center	Jerusalem	En recrutement
Galiee Medical Center	Nahariya	En recrutement
Tel Aviv Sourasky (Ichilov) Medical Center	Tel Aviv	En recrutement
Poriya Medical Center	Tiberias	En recrutement

Spain

Spain
Établissement	Ville	État ou région	Statut
Hospital Universitari Germans Trias i Pujol	Badalona		En recrutement

United States

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

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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