NCT04820764ClinicalTrials.gov
EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
En resumen
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
De intervención25 participantes buscados12 centros1 país
Categorías
Registrado en 1 registro
- ClinicalTrials.govNCT04820764Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses
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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 2021-03-29; recorded start 2021-07-27
- 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
- Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (CardioMech AS)
- 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.
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.
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: 12 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A pilot-scale study: 25 participants (target), run at 12 sites.
How this score is built
- Enrolment11/40
25 participants (target)
- Site count13/25
12 sites
- Country count0/15
Single country
- Planned duration10/10
Planned over about 123 months
- Sponsor scale0/10
CardioMech AS has led 1 trials in our corpus
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
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Afecciones
- Mitral Regurgitation
Elegibilidad
| Sexo | Todos |
|---|---|
| Edades | 18 Years – Sin máximo |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
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
| Tipo de estudio | De intervención |
|---|---|
| Fase | No aplicable |
| Asignación | No aplicable |
| Modelo de intervención | SINGLE_GROUP |
| Propósito principal | DEVICE_FEASIBILITY |
| Enmascaramiento | NONE (0) |
| Inscripción | 25 participantes buscados |
Patrocinador y colaboradores
- CardioMech AS Patrocinador
Grupos e intervenciones
- CardioMech Mitral Valve Repair System (MVRS)EXPERIMENTAL
Intervenciones
- Dispositivo CardioMech MVRS
CardioMech MVRS
Variables de resultado
Variable de resultado principal
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Plazo 30 days
Variable de resultado principal
Change in MR grade
Plazo 30 days
Fechas
| Fecha de inicio | 27 de julio de 2021 (real) |
|---|---|
| Finalización principal | 1 de septiembre de 2026 (estimada) |
| Finalización | 1 de septiembre de 2031 (estimada) |
| Primera publicación | 29 de marzo de 2021 (real) |
| Última actualización | 10 de febrero de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | enero de 2026 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
10 centros están en reclutamiento
United States
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | Activo, sin reclutar |
| The Christ Hospital | Cincinnati | Ohio | En reclutamiento |
| Cleveland Clinic | Cleveland | Ohio | En reclutamiento |
| Northwestern University | Evanston | Illinois | En reclutamiento |
| Intermountain Medical Center | Murray | Utah | En reclutamiento |
| Ascension St. Thomas West | Nashville | Tennessee | En reclutamiento |
| NYU Langone | New York | New York | En reclutamiento |
| Baylor Scott & White, The Heart Hospital | Plano | Texas | En reclutamiento |
| Mayo Clinic | Rochester | Minnesota | En reclutamiento |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | En reclutamiento |
| Cardiovascular Institute of Los Robles Health System | Thousand Oaks | California | Activo, sin reclutar |
| Ascension St. Francis via Christi | Wichita | Kansas | En reclutamiento |
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
No se han registrado cambios desde que incorporamos este registro por primera vez.
Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.