Clinical trial NCT05061004: Cephea Early Feasibility Study
Official title: Cephea Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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) 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.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 days post implant
measure: Primary Effectiveness Endpoint
timeFrame: 30 days post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California - Davis Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Wichita
country: United States
facility: Via Christi Regional Medical Center - St. Francis Campus
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Heart & Vascular Institute
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec
Study officials:
affiliation: Abbott Structural Heart
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References: