Feasibility Study of the Tioga TMVR System

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

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

Key facts

Study ID

NCT06038838

Run by

Tioga Cardiovascular, Inc.

People needed

30

Starts

2024-04-01

Expected to finish

2028-07-01

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Incor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo, Brazil (enrolling)
• Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore) — Tbilisi, Georgia (enrolling)
• Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (enrolling)
• Vilnius Univ. Hospital — Vilnius, Lithuania (enrolling)
• Sanatorio Italiano — Asunción, Paraguay (enrolling)

Full record on ClinicalTrials.gov

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