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Clinical Trials in the USA / NCT05061004
Recruiting Not applicable

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
No
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)

FacilityCityRegionStatus
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

More Abbott Medical Devices trials in the USA

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial Active, not recruiting
ASCEND CSP IDE Study Active, not recruiting
Abbott Medical - VERITAS Study Active, not recruiting
Health App Data Collection Study Enrolling by invitation
AVEIR DR Coverage With Evidence Development (CED) Study Active, not recruiting

Other trials for the same condition

ATLAS (AltaValve) Pivotal Trial Recruiting
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System Recruiting
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study Recruiting
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR. Recruiting
The ENCIRCLE Trial Active, not recruiting
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