An interventional study of Cephea Mitral Valve System in Mitral Valve Disease, Mitral Annulus Calcification and Mitral Regurgitation, sponsored by Abbott Medical Devices. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
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Among 30 studies in Mitral Valve Insufficiency by Abbott — 4 open to participants now, 10 under way, none of them phase 3. Mitral Valve Insufficiency · Abbott.
Among the 30 studies in Mitral Valve Insufficiency by Abbott, this one is the 3rd largest by planned enrollment of the 21 interventional ones that give a count, is the only one that started in 2026, is one of 19 with no phase, and was the 30th registered.
470 studies on the registry are indexed under Mitral Valve Insufficiency; 166 are open to participants now.
Browse Mitral Valve Insufficiency studies →4 of the 30 studies in Mitral Valve Insufficiency by Abbott are open now, in 8 countries. Recruiting first, the newest first:
Abbott Medical Devices · Sites in United States
Ages 18+
Abbott Medical Devices · Sites in United States, Canada
Ages 18+
Abbott Medical Devices · Sites in United States, Estonia, France and 4 more countries
Ages 18+
By country, each count listing its studies:
Of the 123 Mitral Valve Insufficiency studies recruiting now, 102 (83%) set no upper age limit and 6 (5%) stop at 75 or younger; 13 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1
First in 2003; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 565 is above the median of 69 across 280 interventional studies indexed under Mitral Valve Insufficiency.
Median enrollment 90 across the 21 interventional studies, 550 across the 9 observational. Of the 20 that completed or were terminated, 14 (70%) have results posted.
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This study is registered under Abbott Medical Devices, one of the names counted as Abbott. Under that name alone:
Abbott Medical Devices is the lead sponsor of 540 studies on the registry; 34 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
1 of the studies in Mitral Valve Insufficiency by Abbott that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05061004Abbott Medical DevicesCephea Early Feasibility Study | 2026-12-31 |
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Among the 30 studies in Mitral Valve Insufficiency by Abbott, from their registry updates:
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The objective of this clinical trial is to evaluate the safety and effectiveness of the Cephea Mitral Valve System in subjects with symptomatic mitral valve disease (MVD) or are deemed unsuitable for surgery and transcatheter repair.
This is a global, prospective interventional multi-center study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Mitral valve dysfunction meeting one of the following severity criteria:
a. Mitral Annular Calcification (MAC) associated with at least one of the following: i. Grade III or higher mitral regurgitation (MR) ii. Severe mitral stenosis (MS) iii. Concomitant moderate (Grade II) MR and moderate MS b. Grade III or higher MR of primary or secondary etiology
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inclusive of subjects who have moderate-to-severe or severe Mitral Regurgitation
Device: Cephea Mitral Valve System
Inclusive of subjects with mitral valve dysfunction associated with MAC
Device: Cephea Mitral Valve System
During the transcatheter mitral valve replacement procedure, the Cephea Mitral Valve will be placed via transseptal approach
Primary Effectiveness Endpoint
Freedom from all-cause mortality and heart failure hospitalization
Time frame: 12 months post index procedure.
Primary Safety Endpoint
Incidence rate of the composite event of cardiovascular death, stroke, life-threatening bleeding, valve thrombosis, or paravalvular leak with hemolysis.
Time frame: 30 days post index procedure
Change in mitral regurgitation severity from baseline as assessed by the echocardiography core laboratory.
Mitral regurgitation will be graded on a scale from None (least) to Grade IV (most).
Time frame: 12 months post index procedure
Change in Quality of Life from baseline as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score
The overall summary score can range from 0-100, with higher scores representing a better quality of life.
Time frame: 12 months post index procedure
Change in the New York Heart Association Functional Classification of at least one grade from baseline.
New York Heart Association (NYHA) Functional Classification places patients in one of four classes based on their physical activity limitations, with Class I representing the least severe symptoms and increasing classifications representing more severe symptoms. Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort
Time frame: 12 months post index procedure
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2031, 62 months after the start.
Of 91 industry-sponsored interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 144. This study's planned 62 months is close to that.
Counting every sponsor, half of 144 studies reached it within 56 months; a quarter within 25 and three quarters within 108.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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