Phase
Condition
Heartburn (Pediatric)
Esophageal Disorders
Congestive Heart Failure
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Symptomatic mitral valve disease resulting in mitral regurgitation and/or severemitral valve stenosis.
New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
In the judgement of the Site Heart Team, transcatheter therapy is deemed to be moreappropriate than conventional mitral valve surgery, TMVR is more likely to providean optimal result than TEER, and the subject has been adequately treated perapplicable standards, including for coronary artery disease, left ventriculardysfunction, and heart failure.
Age 18 years or older at time of consent.
The subject agrees to the study requirements, permits all follow-up data entry, andhas provided written informed consent.
Exclusion
Exclusion Criteria:
Prior surgical or interventional treatment that interferes with the Cephea valvedelivery or function.
Subject is undergoing dialysis or experiencing chronic renal failure
Subject has chronic lung disease requiring continuous home oxygen therapy or chronicoutpatient oral steroid use
Subjects with comorbidities that are likely to result in a life expectancy of lessthan 12 months.
Pregnant or nursing subjects and those who plan pregnancy during the follow-upperiod.
Study Design
Connect with a study center
Phoenix Cardiovascular Research Group
Phoenix, Arizona 85016
United StatesActive - Recruiting
Phoenix Cardiovascular Research Group
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Los Robles Regional Medical Center
Thousand Oaks, California 91360
United StatesActive - Recruiting
Los Robles Regional Medical Center
Thousand Oaks 5402405, California 5332921 91360
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesActive - Recruiting
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesActive - Recruiting
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Ascension St. Vincent
Indianapolis, Indiana 46240
United StatesActive - Recruiting
Ascension St. Vincent
Indianapolis 4259418, Indiana 4921868 46240
United StatesSite Not Available
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas 67214
United StatesActive - Recruiting
Via Christi Regional Medical Center - St. Francis Campus
Wichita 4281730, Kansas 4273857 67214
United StatesSite Not Available
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Providence St. Patrick Hospital
Missoula, Montana 59802
United StatesActive - Recruiting
Providence St. Patrick Hospital
Missoula 5666639, Montana 5667009 59802
United StatesSite Not Available
St. Francis Hospital
Roslyn, New York 11576
United StatesActive - Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United StatesActive - Recruiting
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Allegheny General Hospital - ASRI
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesSite Not Available
Ascension Saint Thomas
Nashville, Tennessee 37205
United StatesActive - Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee 37203
United StatesActive - Recruiting
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
United StatesActive - Recruiting
Ascension Saint Thomas
Nashville 4644585, Tennessee 4662168 37205
United StatesSite Not Available
TriStar Centennial Medical Center
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Vanderbilt Heart & Vascular Institute
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
Houston Methodist
Houston, Texas 77030
United StatesActive - Recruiting
UTHealth Memorial Hermann
Houston, Texas 77030
United StatesActive - Recruiting
Houston Methodist
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
UTHealth Memorial Hermann
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
United StatesSite Not Available

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