Feasibility Study of the Tioga TMVR System

Study Overview
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Brief Summary
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The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)

Detailed Description
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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+).

Official Title
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Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: Tioga TMVR System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Symptomatic MR (MR>=3+)<br>Subjects treated with the Tioga TMVR System | Device: Tioga TMVR System<br>* A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure | From index procedure (Day 0) to 30 days post-procedure | 
| Primary Performance Endpoint | Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab: Absence of procedural mortality Successful access, delivery, and retrieval of the device delivery system Successful deployment and correct positioning of the first intended device Freedom from emergency surgery or reintervention related to the device or access procedure | At completion of index procedure (Day 0) |