RecruitingNot ApplicableNCT06038838

Feasibility Study of the Tioga TMVR System

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

Sponsor

Tioga Cardiovascular, Inc.

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

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+)

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria28

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