NCT05061004ClinicalTrials.gov

Cephea Early Feasibility Study

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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…

Interventionell90 Teilnehmende gesucht22 Studienzentren2 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT05061004Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert letzte Woche

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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.

Zusammenfassung

Erkrankungen

Mitral Regurgitation

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

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

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Nicht zutreffend
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	90 Teilnehmende gesucht

Sponsor und Mitwirkende

Abbott Medical Devices Sponsor

Studienarme und Interventionen

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

Interventionen

Medizinprodukt Cephea Mitral Valve System
Transcatheter mitral valve replacement

Endpunkte

Primärer Endpunkt
Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Zeitrahmen 30 days post implant
Primärer Endpunkt
Primary Effectiveness Endpoint
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
Zeitrahmen 30 days post implant

Daten

Daten
Startdatum	28. April 2022 (tatsächlich)
Primärer Abschluss	31. Dezember 2026 (geschätzt)
Abschluss	1. März 2031 (geschätzt)
Erstveröffentlichung	29. September 2021 (tatsächlich)
Zuletzt aktualisiert	11. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Dezember 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

20 Studienzentren rekrutieren

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Institut de Cardiologie de Montreal	Montreal	Quebec	Abgeschlossen
IUCPQ-ULaval	Québec	Quebec	Zurückgezogen

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

11. September 2026
Teilnahmeziel geändert
Enrollment target revised up from 50 to 90
5090

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