NCT04820764ClinicalTrials.gov
EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
In breve
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Interventistico25 partecipanti ricercati12 centri1 paese
Categorie
Registrato in 1 registro
- ClinicalTrials.govNCT04820764Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa
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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.
- 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.
Sintesi
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Patologie
- Mitral Regurgitation
Idoneità
| Sesso | Tutti |
|---|---|
| Età | 18 Years – Nessun massimo |
| Volontari sani | No |
Idoneità come riportata nel registro
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
| Tipo di studio | Interventistico |
|---|---|
| Fase | Non applicabile |
| Assegnazione | Non applicabile |
| Modello di intervento | SINGLE_GROUP |
| Finalità principale | DEVICE_FEASIBILITY |
| Mascheramento | NONE (0) |
| Arruolamento | 25 partecipanti ricercati |
Sponsor e collaboratori
- CardioMech AS Sponsor
Bracci e interventi
- CardioMech Mitral Valve Repair System (MVRS)EXPERIMENTAL
Interventi
- Dispositivo CardioMech MVRS
CardioMech MVRS
Esiti misurati
Esito primario
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Orizzonte temporale 30 days
Esito primario
Change in MR grade
Orizzonte temporale 30 days
Date
| Data di inizio | 27 luglio 2021 (effettiva) |
|---|---|
| Conclusione primaria | 1 settembre 2026 (stimata) |
| Conclusione | 1 settembre 2031 (stimata) |
| Prima pubblicazione | 29 marzo 2021 (effettiva) |
| Ultimo aggiornamento | 10 febbraio 2026 |
| Risultati pubblicati | Non indicato nella scheda del registro |
| Stato verificato l'ultima volta | gennaio 2026 |
«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.
Centri
10 centri stanno reclutando
United States
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | Attivo, non in reclutamento |
| The Christ Hospital | Cincinnati | Ohio | In reclutamento |
| Cleveland Clinic | Cleveland | Ohio | In reclutamento |
| Northwestern University | Evanston | Illinois | In reclutamento |
| Intermountain Medical Center | Murray | Utah | In reclutamento |
| Ascension St. Thomas West | Nashville | Tennessee | In reclutamento |
| NYU Langone | New York | New York | In reclutamento |
| Baylor Scott & White, The Heart Hospital | Plano | Texas | In reclutamento |
| Mayo Clinic | Rochester | Minnesota | In reclutamento |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | In reclutamento |
| Cardiovascular Institute of Los Robles Health System | Thousand Oaks | California | Attivo, non in reclutamento |
| Ascension St. Francis via Christi | 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.