An interventional study of Cephea Mitral Valve System in Mitral Regurgitation, sponsored by Abbott Medical Devices. Recruiting at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
Among 28 studies in Mitral Valve Insufficiency by Abbott Medical Devices — 3 open to participants now, 9 under way, none of them phase 3. Mitral Valve Insufficiency · Abbott Medical Devices.
Among the 28 studies in Mitral Valve Insufficiency by Abbott Medical Devices, this one is the 10th largest by planned enrollment of the 19 interventional ones, is the only one that started in 2022, is one of 17 with no phase, and was the 25th registered.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 90 is above the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →3 of the 28 studies in Mitral Valve Insufficiency by Abbott Medical Devices are open now, in 8 countries. Each count lists the studies.
Of the 122 Mitral Valve Insufficiency studies recruiting now, 101 (83%) set no upper age limit and 6 (5%) stop at 75 or younger; 13 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2022.
Median enrollment 90 across the 19 interventional studies, 550 across the 9 observational. Of the 19 that completed or were terminated, 14 (74%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 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 Medical Devices 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 |
Among the 28 studies in Mitral Valve Insufficiency by Abbott Medical Devices, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Key Inclusion Criteria:
Key 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 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.
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.
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
Device: Cephea Mitral Valve System
Transcatheter mitral valve replacement
Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Time frame: 30 days post implant
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
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Dec 2026, 56 months after the start.
Of 90 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 56 months is close to that.
Counting every sponsor, half of 143 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.
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