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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

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.

Osservazionale500 partecipanti ricercati45 centri3 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

ClinicalTrials.govNCT06378632Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

Heart Failure

Idoneità

Idoneità
Sesso	Tutti
Età	22 Years – Nessun massimo
Volontari sani	No
Metodo di campionamento	NON_PROBABILITY_SAMPLE

Popolazione dello studio

Outpatient clinics

Idoneità come riportata nel registro

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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Osservazionale
Fase	Non indicato nella scheda del registro
Assegnazione	Non indicato nella scheda del registro
Modello di intervento	Non indicato nella scheda del registro
Finalità principale	Non indicato nella scheda del registro
Mascheramento	Non indicato nella scheda del registro
Arruolamento	500 partecipanti ricercati

Sponsor e collaboratori

Cordio Medical Sponsor

Interventi

Dispositivo Hearo App
No intervention - only data collection

Esiti misurati

Esito primario
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
Orizzonte temporale 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

Date

Date
Data di inizio	11 febbraio 2022 (effettiva)
Conclusione primaria	1 luglio 2025 (stimata)
Conclusione	15 luglio 2025 (stimata)
Prima pubblicazione	22 aprile 2024 (effettiva)
Ultimo aggiornamento	26 marzo 2025
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	marzo 2025

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

45 centri stanno reclutando

Israel

Israel
Struttura	Città	Stato
University Hospital Samson Assuta Ashdod	Ashdod	In reclutamento
Assuta Be'er Sheva Medical Center	Beersheba	In reclutamento
Rambam Medical Center	Haifa	In reclutamento
Shaare Zedek Medical Center	Jerusalem	In reclutamento
Galiee Medical Center	Nahariya	In reclutamento
Tel Aviv Sourasky (Ichilov) Medical Center	Tel Aviv	In reclutamento
Poriya Medical Center	Tiberias	In reclutamento

Spain

Spain
Struttura	Città	Stato o regione	Stato
Hospital Universitari Germans Trias i Pujol	Badalona		In reclutamento

United States

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

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

Registro: ClinicalTrials.gov · NCT########

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