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NCT05061004ClinicalTrials.gov

Cephea Early Feasibility Study

RecruitingTaking participants now, according to the registry record.
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In brief

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…

Interventional90 participants sought22 sites2 countries

Categories

Cardiovascular100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

  • Registered before enrolment beganFirst posted 2021-09-29; recorded start 2022-04-28
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 82 other studies in this databaseCounted from the lead sponsor named in the record (Abbott Medical Devices)
  • 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.

Summary

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 whom transcatheter therapy is deemed more appropriate than open heart surgery.

Conditions

  • Mitral Regurgitation

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationNot applicable
Intervention modelSINGLE_GROUP
Primary purposeTREATMENT
MaskingNONE (0)
Enrolment90 participants sought

Sponsor and collaborators

  • Abbott Medical Devices Sponsor

Arms and interventions

  • 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

Interventions

  • Device Cephea Mitral Valve System

    Transcatheter mitral valve replacement

Outcome measures

  1. Primary outcome

    Primary Safety Endpoint

    Freedom from all-cause mortality, which will be assessed at 30 days post implant.

    Time frame 30 days post implant

  2. Primary outcome

    Primary Effectiveness Endpoint

    Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.

    Time frame 30 days post implant

Dates

Start dateApril 28, 2022 (actual)
Primary completionDecember 31, 2026 (estimated)
CompletionMarch 1, 2031 (estimated)
First postedSeptember 29, 2021 (actual)
Last updatedSeptember 11, 2026
Results postedNot stated in the registry record
Status last verifiedDecember 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

20 sites are recruiting

Canada

FacilityCityState or regionStatus
Institut de Cardiologie de MontrealMontrealQuebecCompleted
IUCPQ-ULavalQuébecQuebecWithdrawn

United States

FacilityCityState or regionStatus
University of Michigan - Davis Medical CenterAnn ArborMichiganRecruiting
Piedmont Heart InstituteAtlantaGeorgiaRecruiting
Emory University HospitalAtlantaGeorgiaRecruiting
Atrium Health - Carolinas Medical CenterCharlotteNorth CarolinaRecruiting
Northwestern Memorial HospitalChicagoIllinoisRecruiting
The Cleveland Clinic FoundationClevelandOhioRecruiting
Houston MethodistHoustonTexasRecruiting
Cedars-Sinai Medical CenterLos AngelesCaliforniaRecruiting
Minneapolis Heart InstituteMinneapolisMinnesotaRecruiting
Ascension Saint ThomasNashvilleTennesseeRecruiting
Vanderbilt Heart & Vascular InstituteNashvilleTennesseeRecruiting
New York-Presbyterian/Columbia University Medical CenterNew YorkNew YorkRecruiting
Sentara Norfolk General HospitalNorfolkVirginiaRecruiting
Banner-University Medical Center PhoenixPhoenixArizonaRecruiting
Allegheny General Hospital - ASRIPittsburghPennsylvaniaRecruiting
University of California - Davis Medical CenterSacramentoCaliforniaRecruiting
Swedish Medical CenterSeattleWashingtonRecruiting
Montefiore Medical Center - Moses CampusThe BronxNew YorkRecruiting
Los Robles Regional Medical CenterThousand OaksCaliforniaRecruiting
Ascension Via Christi Hospitals WichitaWichitaKansasRecruiting

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 11, 2026

    Enrolment target changed

    Enrollment target revised up from 50 to 90

    5090

Registry: ClinicalTrials.gov · NCT########

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