NCT04820764ClinicalTrials.gov
EFS of the CardioMech MVRS
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Kurz gefasst
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Interventionell25 Teilnehmende gesucht12 Studienzentren1 Land
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT04820764Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten
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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.
Zusammenfassung
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Erkrankungen
- Mitral Regurgitation
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – Kein Höchstalter |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Nicht zutreffend |
| Zuteilung | Nicht zutreffend |
| Interventionsmodell | SINGLE_GROUP |
| Primäres Ziel | DEVICE_FEASIBILITY |
| Verblindung | NONE (0) |
| Teilnahme | 25 Teilnehmende gesucht |
Sponsor und Mitwirkende
- CardioMech AS Sponsor
Studienarme und Interventionen
- CardioMech Mitral Valve Repair System (MVRS)EXPERIMENTAL
Interventionen
- Medizinprodukt CardioMech MVRS
CardioMech MVRS
Endpunkte
Primärer Endpunkt
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Zeitrahmen 30 days
Primärer Endpunkt
Change in MR grade
Zeitrahmen 30 days
Daten
| Startdatum | 27. Juli 2021 (tatsächlich) |
|---|---|
| Primärer Abschluss | 1. September 2026 (geschätzt) |
| Abschluss | 1. September 2031 (geschätzt) |
| Erstveröffentlichung | 29. März 2021 (tatsächlich) |
| Zuletzt aktualisiert | 10. Februar 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Januar 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
10 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Atrium Health Sanger Heart and Vascular Institute | Charlotte | North Carolina | Aktiv, rekrutiert nicht |
| The Christ Hospital | Cincinnati | Ohio | Rekrutiert |
| Cleveland Clinic | Cleveland | Ohio | Rekrutiert |
| Northwestern University | Evanston | Illinois | Rekrutiert |
| Intermountain Medical Center | Murray | Utah | Rekrutiert |
| Ascension St. Thomas West | Nashville | Tennessee | Rekrutiert |
| NYU Langone | New York | New York | Rekrutiert |
| Baylor Scott & White, The Heart Hospital | Plano | Texas | Rekrutiert |
| Mayo Clinic | Rochester | Minnesota | Rekrutiert |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | Rekrutiert |
| Cardiovascular Institute of Los Robles Health System | Thousand Oaks | California | Aktiv, rekrutiert nicht |
| Ascension St. Francis via Christi | Wichita | Kansas | Rekrutiert |
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.
Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.