|
Cephea Early Feasibility Study
RECRUITINGN/ASponsored by Abbott Medical Devices
Actively Recruiting
PhaseN/A
SponsorAbbott Medical Devices
Started2022-04-28
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations20 sites
View on ClinicalTrials.gov →
NCT05061004
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. * Need for emergent or urgent surgery.
Conditions2
Heart DiseaseMitral Regurgitation
Locations20 sites
Cedars-Sinai Medical Center
University of California - Davis Medical Center
Los Robles Regional Medical Center
Emory University Hospital
Find trials near these locations
Heart Disease trials in PhoenixHeart Disease trials in Los AngelesHeart Disease trials in SacramentoHeart Disease trials in AtlantaHeart Disease trials in ChicagoHeart Disease trials in MinneapolisHeart Disease trials in New YorkHeart Disease trials in CharlotteHeart Disease trials in ClevelandHeart Disease trials in NashvilleHeart Disease trials in HoustonHeart Disease trials in SeattleAll trials in ArizonaAll trials in CaliforniaAll trials in GeorgiaAll trials in IllinoisAll trials in MinnesotaAll trials in New YorkAll trials in North CarolinaAll trials in OhioAll trials in PennsylvaniaAll trials in TennesseeAll trials in TexasAll trials in VirginiaAll trials in Washington
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhaseN/A
SponsorAbbott Medical Devices
Started2022-04-28
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations20 sites
View on ClinicalTrials.gov →
NCT05061004