Recruiting

Mitral Valve Disease

Sponsor:

Abbott Medical Devices

Code:

NCT07069673

Conditions

Mitral Regurgitation

Mitral Stenosis

Mitral Valve Disease

Mitral Valve (MV) Regurgitation

Mitral Annulus Calcification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.

Conditions

Mitral Regurgitation

Mitral Stenosis

Mitral Valve Disease

Mitral Valve (MV) Regurgitation

Mitral Annulus Calcification

Study ID

NCT07069673

Start date

Aug 13, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
4. Age 18 years or older at time of consent.
5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.

Exclusion Criteria:

1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
2. Subject is undergoing dialysis or experiencing chronic renal failure
3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Potential transcatheter mitral valve replacement (TMVR) candidates

Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.

Primary outcome measure

  • Primary Objective [ Time Frame: From enrollment to 2 years of follow-up ]

Central Contacts and Locations

Central contacts

Locations

University Hospital - Univ. of Alabama at Birmingham (UAB)

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Mustafa Ahmed, MD

Phoenix Cardiovascular Research Group

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Principal Investigator:

Timothy Byrne, DO, FACC

Los Robles Regional Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Principal Investigator:

Saibal Kar, MD

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Principal Investigator:

Pradeep Yadav, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Adam Greenbaum, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Anita Asgar, MD

Ascension St. Vincent

Recruiting

Indianapolis, Indiana, United States, 46240

Contacts

Jena Stanley, BSN, RN, CCRN-K

317-583-6115jena.stanley@ascension.org

Principal Investigator:

Ezequiel Munoz, MD

Via Christi Regional Medical Center - St. Francis Campus

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Principal Investigator:

Bassem Chehab, MD

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Mario Goessl, MD

Providence St. Patrick Hospital

Recruiting

Missoula, Montana, United States, 59802

Contacts

Principal Investigator:

Daniel Spoon, MD

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Elizabeth Haag, RN, BSN, CCRP

516-562-6790Elizabeth.Haag@chsli.org

Principal Investigator:

William Chung, MD

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Andrea Scotti, MD

Atrium Health - Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Principal Investigator:

Michael Rinaldi, MD

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Amar Krishnaswamy, MD

Allegheny General Hospital - ASRI

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Principal Investigator:

Walter McGregor, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Daniel Steinberg, MD

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Andrew Goodman, MD

Ascension Saint Thomas

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Principal Investigator:

Evelio Rodriguez, MD

Vanderbilt Heart & Vascular Institute

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Kashish Goel, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Sachin Goel, MD

UTHealth Memorial Hermann

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Biswajit Kar, MD

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Principal Investigator:

Brian Whisenant, MD

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Principal Investigator:

Matthew Summers, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Mitral Valve Disease
  • registry
  • Cephea Mitral Valve System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-06-22.