IRB Study Number 26-290
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this registry is to learn more about mitral valve disease (MVD) progression and effects. A registry is where data from patients is collected to learn more about a disease and how best to treat it. Registries may assist healthcare providers with making informed decisions on how to best treat their patients. The medical data collected for this registry will also help decide if you may be a candidate for an Abbott heart valve, as well as help develop future treatments for MVD. If you are a potential candidate for an Abbott heart valve, you may be given the opportunity to participate in a different clinical research study. Your doctor will talk to you separately about the options you have. This registry includes sharing your medical data with the sponsor. There are no additional medical procedures that are required to be completed by this registry. Participation in the research will last for about 24 months.
Inclusion Criteria
Symptomatic mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm2) or both moderate MR and moderate MS, per American Society of Echocardiography criteria.
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 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.
LVEF ≥ 30%
LVEDD ≤ 70 mm
Age 18 years or older at time of consent.
The subject has been informed of the nature of the study, agrees to its provisions and permitting all follow-up data entry, and has provided written informed consent.
Exclusion Criteria
Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
Implant or revision of CRT device within 90 days prior to subject consent. Note: Generator replacement without programming changes is allowed.
Myocardial infarction within 30 days prior to subject consent.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation at risk of embolization.
Untreated clinically significant coronary artery disease requiring surgery or transcatheter intervention.
Aortic valve disease requiring surgery or transcatheter intervention.
Severe tricuspid regurgitation, or tricuspid valve disease requiring surgery or transcatheter intervention.
Evidence of right-sided congestive heart failure or significant right ventricular dysfunction.
Subject is undergoing dialysis or experiencing chronic renal failure (eGFR≤29).
Subject has pulmonary arterial hypertension (fixed PAS >60mmHg). Note: If PAS > 60mmHg site must provide documentation PAS is not fixed to be eligible.
Prior orthotopic heart transplantation.
Unresolved severe carotid stenosis (>70% by ultrasound), or symptomatic carotid stenosis of any severity.
Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support within 90 days prior to consent.
Hypertrophic or restrictive cardiomyopathy (including but not limited to amyloidosis, hemochromatosis, sarcoidosis), or constrictive pericarditis.
Any of the following if cannot be adequately treated: leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
Subject in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
Cerebrovascular accident (CVA) within 6 months prior to consent.
Modified Rankin Scale ≥ 4 disability.
Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
Currently participating in an investigational drug or device study that has not reached its primary endpoint. Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies.
The presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator’s opinion, could limit the subject’s ability to participate in the study or to comply with follow-up requirements.
