Mitral valve/cardiac anatomy that will preclude safe and effective delivery or deployment of the INNOVALVE system, including, but not limited to:
Significant prolapse or other leaflet anatomy that may lead to suboptimal results
Moderate or severe mitral annular calcification (MAC)
Left ventricular end-diastolic diameter ≥ 75 mm
Significant risk of LVOT obstruction
Inappropriate anatomy for femoral introduction and delivery of the INNOVALVE system
Presence of any device that will preclude safe and effective delivery or deployment of the INNOVALVE system
Previous mitral intervention that could interfere with placement or function of the INNOVALVE system
Need for emergent or urgent surgery for any reason, or planned surgery requiring prolonged recovery or inactivity and/or reduced mobility within the next 365 days (1 year)
Any of the following cardiovascular procedures or other devices or procedures that may affect procedural outcomes:
Percutaneous coronary, intracardiac, or endovascular intervention within 30 days
Carotid surgery within 30 days
Direct current cardioversion within 30 days
Pacemaker or ICD implantation within 30 days
Left atrial appendage occlusion placement within 30 days
Ablation for atrial fibrillation or ventricular arrhythmias within 30 days
Cardiac surgery within 90 days
Severe aortic, tricuspid, and/or pulmonary valve stenosis and/or regurgitation
Severe right ventricular (RV) dysfunction
Left ventricular ejection fraction < 25%
Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or uncorrected, significant congenital heart disease (including, but not limited to, ventricular septal defects)
Patients with refractory heart failure requiring or that required advanced intervention (i.e., left ventricular assist device, prior heart transplant, heart transplant status ≤ 5 or equivalent)
Recent hemodynamic instability (e.g., need for inotropic support, intraaortic balloon pump, or other hemodynamic support device)
Clinically significant, untreated coronary artery disease (CAD) requiring revascularization, unstable angina, evidence of acute coronary syndrome, or recent myocardial infarction (per World Health Organization [WHO] definition)
Echocardiographic evidence of significant intra-cardiac mass, thrombus, or vegetation
Active bacterial endocarditis
Infection requiring current antibiotic therapy (oral or intravenous) within 14 days
Recent stroke or transient ischemic attack (TIA)
Modified Rankin Scale (mRS) ≥ 4 disability
Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization (RHC), unless a vasodilator challenge is able to reduce pulmonary vascular resistance (PVR) to < 3 Wood units, or to between 3 and 4.5 Wood units with a V wave less than twice the mean pulmonary capillary wedge pressure
Chronic pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 or requiring renal replacement therapy
Patients with hepatic insufficiency or cirrhosis with Child-Pugh Score class B or C
Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
Known bleeding or clotting disorders or patient refuses blood products
Deep vein thrombosis or pulmonary embolism
Chronic anemia with transfusion dependency or hemoglobin < 9 g/dL not corrected by transfusion
Recent, active gastrointestinal bleeding
Thrombocytopenia (platelet count < 75,000/mm3) or thrombocytosis (platelet count > 750,000/mm3) 29 Patients in whom any of the following is true:
A TEE is contraindicated or cannot be completed
Mitral valve anatomy is not evaluable by TTE or TEE
Screening TEE imaging is sub-optimal for visibility and guidance during the procedure and follow-up evaluations
Pregnant, breastfeeding, or planning pregnancy within next 365 days (1 year)
Any physical impairment limiting the patient’s capacity to complete functional testing due to other medical conditions independent of their MR (e.g., orthopedic condition)
Comorbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 365 days (1 year)
Patients currently participating in another investigational biologic, drug, or device clinical study, and the patient has not reached the primary study endpoint
Any condition, in the opinion of the Investigator, that may prevent the patient from completing all protocol procedures and follow-up visits
Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including being under guardianship
Patients considered to be part of a vulnerable population as defined in ISO 1455