NCT06038838 Feasibility Study of the Tioga TMVR System

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2024-04-01 with a primary completion date of 2026-07-01.

Brief Summary

The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating 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 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

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