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Cephea Early Feasibility Study for Mitral Valve Disease

This study is testing a new device called the Cephea Mitral Valve System. This system is designed to replace your mitral valve without open-heart surgery, which is a procedure called transcatheter mitral valve replacement. The study aims to see how safe and effective the Cephea Mitral Valve System is for people with symptomatic mitral valve disease, including mitral regurgitation (a leaky heart valve) or mitral stenosis (a narrowed heart valve). You might be able to join if your heart team believes this less invasive procedure is a better option for you than traditional surgery. The study will measure success by looking at safety and effectiveness 30 days after the device is implanted. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 50 participants. The study is evaluating a medical device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and effectiveness for 30 days after the device is implanted.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05061004

Cephea Early Feasibility Study

Recruiting
NAAges 18+InterventionalTreatment
Abbott Medical Devices
~50 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Cephea Mitral Valve System

At a glance

Recruiting sites
20 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over 30 days post implant
+1 more outcome measured

Conditions

Mitral Regurgitation

Explore related trials

Mitral Valve InsufficiencyMitral Valve Stenosis

Where it's being run

22 sites across 16 states
California3
Georgia2
New York2
Tennessee2
Quebec2
Arizona1
Illinois1
Kansas1

Study leadership

  • Barathi Sethuraman · STUDY_DIRECTOR · Abbott Structural Heart

Who to contact

Leslie Centeno
[email protected]
+1 818-294-3041
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) 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.

Exclusion

Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
Need for emergent or urgent surgery.

What this trial measures

  • Primary Safety Endpoint30 days post implant

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

  • Primary Effectiveness Endpoint30 days post implant

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