Recruiting NCT05061004
Cephea Early Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cephea Mitral Valve System.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Cephea Mitral Valve System
Transcatheter mitral valve replacement
Primary outcome measures
- Primary Safety Endpoint [Time frame: 30 days post implant]
- Primary Effectiveness Endpoint [Time frame: 30 days post implant]
Eligibility criteria
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.
Exclusion criteria
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- Need for emergent or urgent surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Banner-University Medical Center Phoenix — Phoenix
- Cedars-Sinai Medical Center — Los Angeles
- University of California - Davis Medical Center — Sacramento
- Los Robles Regional Medical Center — Thousand Oaks
- Emory University Hospital — Atlanta
- Piedmont Heart Institute — Atlanta
- Northwestern Memorial Hospital — Chicago
- Ascension Via Christi Hospitals Wichita — Wichita
- … and 12 more centers
Canada · 2 centers
- Institut de Cardiologie de Montreal — Montreal
- IUCPQ-ULaval — Québec
Identifiers
NCT: NCT05061004 · ABT-CIP-10354