NCT05061004ClinicalTrials.gov

Cephea Early Feasibility Study

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En resumen

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…

De intervención90 participantes buscados22 centros2 países

Categorías

Cardiovascular100%

Registrado en 1 registro

ClinicalTrials.govNCT05061004Abrir este registro en ClinicalTrials.govSincronizado la semana pasada

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

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.

Resumen

Afecciones

Mitral Regurgitation

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el 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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	No aplicable
Asignación	No aplicable
Modelo de intervención	SINGLE_GROUP
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	90 participantes buscados

Patrocinador y colaboradores

Abbott Medical Devices Patrocinador

Grupos e intervenciones

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

Intervenciones

Dispositivo Cephea Mitral Valve System
Transcatheter mitral valve replacement

Variables de resultado

Variable de resultado principal
Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Plazo 30 days post implant
Variable de resultado principal
Primary Effectiveness Endpoint
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
Plazo 30 days post implant

Fechas

Fechas
Fecha de inicio	28 de abril de 2022 (real)
Finalización principal	31 de diciembre de 2026 (estimada)
Finalización	1 de marzo de 2031 (estimada)
Primera publicación	29 de septiembre de 2021 (real)
Última actualización	11 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	diciembre de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

20 centros están en reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Institut de Cardiologie de Montreal	Montreal	Quebec	Completado
IUCPQ-ULaval	Québec	Quebec	Retirado

United States

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

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

11 de septiembre de 2026
Objetivo de inscripción modificado
Enrollment target revised up from 50 to 90
5090

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

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