Mitral Regurgitation
Conditions
Brief 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.
Interventions
Transcatheter mitral valve replacement
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 30 days post implant | Freedom from all-cause mortality, which will be assessed at 30 days post implant. |
| Primary Effectiveness Endpoint | 30 days post implant | Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant. |
Countries
Canada, United States
Contacts
CONTACTLeslie Centeno
CONTACTClinical Project Manager
STUDY_DIRECTORBarathi Sethuraman
Abbott Structural Heart
Outcome results
None listed