Overview
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)
Description
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
Inclusion Criteria:
- Age 18 years or older
- Symptomatic, moderate to severe (3+) or severe (4+) MR
- NYHA Functional Classification ≥ II
- Heart team concurs that the subject is non-ideal for 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 \< 30%
- 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