NCT05061004ClinicalTrials.gov

Cephea Early Feasibility Study

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in…

Interventistico90 partecipanti ricercati22 centri2 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

ClinicalTrials.govNCT05061004Apri questa scheda su ClinicalTrials.govSincronizzato settimana scorsa

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.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

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.

Present: Registered before enrolment beganFirst posted 2021-09-29; recorded start 2022-04-28
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: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
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 82 other studies in this databaseCounted from the lead sponsor named in the record (Abbott Medical Devices)
Present: Sponsor has posted results for at least one studyBased 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
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 22 sites
Data monitoring committee0/7
Data monitoring committee not stated in the record
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study, international in scope: 90 participants (target), run at 22 sites, across 2 countries.

How this score is built

Enrolment15/40
50 participants (target)
Site count16/25
22 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 108 months
Sponsor scale7/10
Abbott Medical Devices has led 83 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

Patologie

Mitral Regurgitation

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel registro

Key Inclusion Criteria: * Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria. * LVEF ≥ 30% * In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery. Key Exclusion Criteria: * Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. * Need for emergent or urgent surgery.

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	Interventistico
Fase	Non applicabile
Assegnazione	Non applicabile
Modello di intervento	SINGLE_GROUP
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	90 partecipanti ricercati

Sponsor e collaboratori

Abbott Medical Devices Sponsor

Bracci e interventi

TreatmentEXPERIMENTAL
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

Interventi

Dispositivo Cephea Mitral Valve System
Transcatheter mitral valve replacement

Esiti misurati

Esito primario
Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Orizzonte temporale 30 days post implant
Esito primario
Primary Effectiveness Endpoint
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
Orizzonte temporale 30 days post implant

Date

Date
Data di inizio	28 aprile 2022 (effettiva)
Conclusione primaria	31 dicembre 2026 (stimata)
Conclusione	1 marzo 2031 (stimata)
Prima pubblicazione	29 settembre 2021 (effettiva)
Ultimo aggiornamento	11 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	dicembre 2025

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

Centri

20 centri stanno reclutando

Canada

Canada
Struttura	Città	Stato o regione	Stato
Institut de Cardiologie de Montreal	Montreal	Quebec	Completato
IUCPQ-ULaval	Québec	Quebec	Ritirato

United States

United States
Struttura	Città	Stato o regione	Stato
University of Michigan - Davis Medical Center	Ann Arbor	Michigan	In reclutamento
Piedmont Heart Institute	Atlanta	Georgia	In reclutamento
Emory University Hospital	Atlanta	Georgia	In reclutamento
Atrium Health - Carolinas Medical Center	Charlotte	North Carolina	In reclutamento
Northwestern Memorial Hospital	Chicago	Illinois	In reclutamento
The Cleveland Clinic Foundation	Cleveland	Ohio	In reclutamento
Houston Methodist	Houston	Texas	In reclutamento
Cedars-Sinai Medical Center	Los Angeles	California	In reclutamento
Minneapolis Heart Institute	Minneapolis	Minnesota	In reclutamento
Ascension Saint Thomas	Nashville	Tennessee	In reclutamento
Vanderbilt Heart & Vascular Institute	Nashville	Tennessee	In reclutamento
New York-Presbyterian/Columbia University Medical Center	New York	New York	In reclutamento
Sentara Norfolk General Hospital	Norfolk	Virginia	In reclutamento
Banner-University Medical Center Phoenix	Phoenix	Arizona	In reclutamento
Allegheny General Hospital - ASRI	Pittsburgh	Pennsylvania	In reclutamento
University of California - Davis Medical Center	Sacramento	California	In reclutamento
Swedish Medical Center	Seattle	Washington	In reclutamento
Montefiore Medical Center - Moses Campus	The Bronx	New York	In reclutamento
Los Robles Regional Medical Center	Thousand Oaks	California	In reclutamento
Ascension Via Christi Hospitals Wichita	Wichita	Kansas	In reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

11 settembre 2026
Obiettivo di arruolamento modificato
Enrollment target revised up from 50 to 90
5090

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

https://xmedica.io/trials/ctgov/NCT05061004