feasibility study of the tioga tmvr system

Conditions: Mitral Regurgitation

Summary: the study is aimed to assess the safety and feasibility of the tioga tmvr system in treating patients with symptomatic mr (mr\>=3+)

the tioga tmvr feasibility study is a prospective, single-arm, multi-center study with a planned enrollment of up to 30 patients. the tioga tmvr system is designed to percutaneously replace a patient's diseased native mitral valve with a bioprosthetic valve. the investigational device is intended for transseptal replacement of the mitral valve in patients with symptomatic mr (mr\>=3+).

Eligibility criteria:
inclusion criteria: * age 18 years or older * symptomatic, moderate to severe (3+) or severe (4+) mr * nyha functional classification ≥ ii * heart team concurs that tmvr is the preferred treatment over surgical intervention or other available treatment options (e.g., teer) * the subject or the subject's legal representative has been informed of the nature of the study, has agreed to return for post-procedure follow-up visits, and has provided informed consent exclusion criteria: * lvef \< 25% * lvedd \> 70 mm * anatomic features (e.g., annular dimensions, neo-lvot area, transfemoral and transseptal access, mac) unsuitable for the tioga tmvr system * severe aortic valve stenosis or regurgitation * severe right ventricular dysfunction or severe tricuspid valve disease * evidence of intracardiac thrombus, vegetation, or mass * prior mitral valve intervention * prior prosthetic heart valve in any position * any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to enrollment * any carotid surgery within 30 days prior to enrollment * any open cardiac or vascular surgery (other than carotid surgery) within 90 days prior to enrolment * myocardial infarction within 30 days prior to enrollment * cardiac resynchronization therapy (crt) device implanted within 30 days of enrollment * history of endocarditis within 6 months prior to enrollment or evidence of active systemic infection or sepsis. * planned cardiovascular procedure within 30 days of enrolment * cerebrovascular accident (cva) or transient ischemic attack (tia) within 30 days of enrollment * active peptic ulcer or active gi bleeding within 90 days of enrollment * cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical heart assistance * pulmonary arterial hypertension with fixed pasp \> 70mmhg or pvr \> 5wu that cannot be reduced to less than 5wu with vasodilator therapy * severe chronic obstructive pulmonary disease (copd) or airways disease requiring continuous home oxygen * renal insufficiency (egfr \<20 ml/min) or esrd on dialysis * life expectancy \< 12 months * subject is on the waiting list for a transplant or has had a prior heart transplant * child class c cirrhosis * blood dycrasias as defined by acute anemia with hb \< 9, platelets \< 75k, wbc \< 0.5 * female subjects who is breast feeding or pregnant or planning to become pregnant within the study period. * known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution) or hypersensitivity to nickel or titanium * inability to tolerate anticoagulation or antiplatelet therapies