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Abbott Cephea Mitral Valve Disease Registry

RecruitingObservational study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

Sponsor: Abbott Medical Devices · Participants: 1,000 · Started: Aug 13, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07069673

Locations in the U.S.

AlabamaUniversity Hospital - Univ. of Alabama at Birmingham (UAB), Birmingham
ArizonaBanner-University Medical Center Phoenix, Phoenix
Phoenix Cardiovascular Research Group, Phoenix
CaliforniaLos Robles Regional Medical Center, Thousand Oaks
GeorgiaEmory University Hospital, Atlanta
Piedmont Heart Institute, Atlanta
IllinoisNorthwestern Memorial Hospital, Chicago
IndianaAscension St. Vincent, Indianapolis
KansasAscension Via Christi Hospitals Wichita, Wichita
MinnesotaMinneapolis Heart Institute, Minneapolis
MontanaProvidence St. Patrick Hospital, Missoula
New YorkSt. Francis Hospital, Roslyn
Montefiore Medical Center - Moses Campus, The Bronx
North CarolinaAtrium Health - Carolinas Medical Center, Charlotte
OhioThe Cleveland Clinic Foundation, Cleveland
PennsylvaniaAllegheny General Hospital - ASRI, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TennesseeAscension Saint Thomas, Nashville
TriStar Centennial Medical Center, Nashville
Vanderbilt Heart & Vascular Institute, Nashville
TexasHouston Methodist, Houston
UTHealth Memorial Hermann, Houston
UtahIntermountain Medical Center, Murray
VirginiaSentara Norfolk General Hospital, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.