Feasibility Study of the Tioga TMVR System

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

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

Conditions2

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