Cephea Early Feasibility Study

NCT05061004 · tracked via the Priya Life Science USA tracker

Sponsor

Abbott Medical Devices

Phase

Not applicable

Started

2022-04-28

Last updated

2026-09-11

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

Cephea Mitral Valve System

Cephea Mitral Valve System: Transcatheter mitral valve replacement

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (22)

Facility	City	Region	Status
Banner-University Medical Center Phoenix	Phoenix	Arizona	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
University of California - Davis Medical Center	Sacramento	California	Recruiting
Los Robles Regional Medical Center	Thousand Oaks	California	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
Piedmont Heart Institute	Atlanta	Georgia	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	Recruiting
Ascension Via Christi Hospitals Wichita	Wichita	Kansas	Recruiting
University of Michigan - Davis Medical Center	Ann Arbor	Michigan	Recruiting
Minneapolis Heart Institute	Minneapolis	Minnesota	Recruiting
New York-Presbyterian/Columbia University Medical Center	New York	New York	Recruiting
Montefiore Medical Center - Moses Campus	The Bronx	New York	Recruiting
Atrium Health - Carolinas Medical Center	Charlotte	North Carolina	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Allegheny General Hospital - ASRI	Pittsburgh	Pennsylvania	Recruiting
Ascension Saint Thomas	Nashville	Tennessee	Recruiting
Vanderbilt Heart & Vascular Institute	Nashville	Tennessee	Recruiting
Houston Methodist	Houston	Texas	Recruiting
Sentara Norfolk General Hospital	Norfolk	Virginia	Recruiting
Swedish Medical Center	Seattle	Washington	Recruiting
Institut de Cardiologie de Montreal	Montreal	Quebec	Completed
IUCPQ-ULaval	Québec	Quebec	Withdrawn

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05061004 on ClinicalTrials.gov ↗ ← All trials in the USA