NCT04820764ClinicalTrials.gov
EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
En bref
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Interventionnelle25 participants recherchés12 sites1 pays
Catégories
Enregistré dans 1 registre
- ClinicalTrials.govNCT04820764Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois
Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.
Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.
Cette étude vous intéresse ?
Se connecter ou créez un compte pour manifester votre intérêt et suivre cette étude.
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.
Résumé
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Affections
- Mitral Regurgitation
Éligibilité
| Sexe | Tous |
|---|---|
| Âges | 18 Years – Aucun maximum |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
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
| Type d'étude | Interventionnelle |
|---|---|
| Phase | Sans objet |
| Répartition | Sans objet |
| Modèle d'intervention | SINGLE_GROUP |
| Objectif principal | DEVICE_FEASIBILITY |
| Insu | NONE (0) |
| Recrutement | 25 participants recherchés |
Promoteur et collaborateurs
- CardioMech AS Promoteur
Groupes et interventions
- CardioMech Mitral Valve Repair System (MVRS)EXPERIMENTAL
Interventions
- Dispositif CardioMech MVRS
CardioMech MVRS
Critères de jugement
Critère de jugement principal
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Délai 30 days
Critère de jugement principal
Change in MR grade
Délai 30 days
Dates
| Date de début | 27 juillet 2021 (réelle) |
|---|---|
| Achèvement principal | 1 septembre 2026 (estimée) |
| Achèvement | 1 septembre 2031 (estimée) |
| Première publication | 29 mars 2021 (réelle) |
| Dernière mise à jour | 10 février 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | janvier 2026 |
Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.
Lieux
10 sites sont en recrutement
United States
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | Actif, sans recrutement |
| The Christ Hospital | Cincinnati | Ohio | En recrutement |
| Cleveland Clinic | Cleveland | Ohio | En recrutement |
| Northwestern University | Evanston | Illinois | En recrutement |
| Intermountain Medical Center | Murray | Utah | En recrutement |
| Ascension St. Thomas West | Nashville | Tennessee | En recrutement |
| NYU Langone | New York | New York | En recrutement |
| Baylor Scott & White, The Heart Hospital | Plano | Texas | En recrutement |
| Mayo Clinic | Rochester | Minnesota | En recrutement |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | En recrutement |
| Cardiovascular Institute of Los Robles Health System | Thousand Oaks | California | Actif, sans recrutement |
| Ascension St. Francis via Christi | 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.