Experimental heart valve device tested in just one patient — study halted

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 85\>Age ≥ 18 years * Symptomatic (Stage D) severe MR confirmed by the echo core lab * Cardiac Index \> 2.0 * Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE) * New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa * Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure * Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert). Exclusion Criteria: * MR etiology that is exclusively Primary (degenerative) * Echocardiographic or angiographic evidence of severe mitral annular calcification * Echocardiographic evidence of EROA \< 0.3cm2 * Untreated clinically significant coronary artery disease requiring revascularization. * Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology * Hypotension (systolic pressure \< 90 mm Hg)/Cardiogenic shock or other hemodynamic instability requiring the need for inotropic * Fixed pulmonary artery systolic pressure \> 2/3 of systemic systolic blood pressure * LVEDD \>75 mm * Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction. * Anatomy deemed not suitable for the Cardiovalve * Elevated Creatine Kinase-MB (CK-MB) * UNOS Status 1 heart transplant or prior orthotropic heart transplantation. * Life Expectancy \< 1 year due to non-cardiac conditions * NYHA functional class IVb * Chronic Kidney Disease with Creatinine clearance \<30 ml/min/1.73m2 * Any prior mitral valve surgery or transcatheter mitral valve procedure * Stroke or transient ischemic event within 30 Days prior to index procedure * Modified Rankin Scale \> 4 disability * Class I indication for biventricular pacing (in patient with CRT device not implanted) * Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure * Need for cardiovascular surgery (other than MV disease) * Echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Active endocarditis * Known severe symptomatic carotid stenosis (\> 70 % via ultrasound) * Active infections requiring current antibiotic therapy * Active cancer with expected survival \< one year * Pregnant or planning pregnancy within next 12 months. * Currently participating in an investigational drug or another device study * Any condition making it unlikely the patient will be able to complete all procedures * Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment * Subjects in whom transesophageal echocardiography is contraindicated * Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, heparin, anticoagulation therapy) or hypersensitivity to nickel or titanium.