Actively Recruiting
Feasibility Study of the Tioga TMVR System
Led by Tioga Cardiovascular, Inc. · Updated on 2025-11-12
30
Participants Needed
5
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)
CONDITIONS
Official Title
Feasibility Study of the Tioga TMVR System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Symptomatic, moderate to severe (3+) or severe (4+) mitral regurgitation
- NYHA Functional Classification II or higher
- Heart team agrees patient is not an ideal candidate for surgery or other treatments like TEER
- Patient or legal representative has given informed consent and agrees to follow-up visits
You will not qualify if you...
- Left ventricular ejection fraction less than 30%
- Left ventricular end-diastolic diameter greater than 70 mm
- Anatomic features 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
- Percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to enrollment
- Carotid surgery within 30 days prior to enrollment
- Open cardiac or vascular surgery (except carotid surgery) within 90 days prior to enrollment
- Myocardial infarction within 30 days prior to enrollment
- Cardiac resynchronization therapy device implanted within 30 days prior to enrollment
- Endocarditis within 6 months prior to enrollment or active systemic infection/sepsis
- Planned cardiovascular procedure within 30 days of enrollment
- Stroke or transient ischemic attack within 30 days prior to enrollment
- Active peptic ulcer or gastrointestinal bleeding within 90 days of enrollment
- Cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical assistance
- Pulmonary arterial hypertension with fixed PASP > 70 mmHg or PVR > 5 WU unresponsive to vasodilator therapy
- Severe chronic obstructive pulmonary disease or airways disease requiring continuous home oxygen
- Renal insufficiency with eGFR < 20 mL/min or end-stage renal disease on dialysis
- Life expectancy less than 12 months
- On waiting list for transplant or prior heart transplant
- Child class C cirrhosis
- Blood disorders such as acute anemia with hemoglobin < 9, platelets < 75,000, or white blood cells < 0.5
- Female subjects who are breastfeeding, pregnant, or planning pregnancy during the study
- Known allergy or contraindication to procedural or post-procedural medications or to nickel or titanium
- Unable to tolerate anticoagulation or antiplatelet therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Incor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, Brazil
Actively Recruiting
2
Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)
Tbilisi, Georgia
Actively Recruiting
3
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Actively Recruiting
4
Vilnius Univ. Hospital
Vilnius, Lithuania
Actively Recruiting
5
Sanatorio Italiano
Asunción, Paraguay
Actively Recruiting
Research Team
M
Mariam Maghribi
CONTACT
T
Tom Kelly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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