What is the Tioga TMVR System studying for mitral regurgitation?

The Tioga TMVR System is being studied to assess its safety and feasibility in treating patients with symptomatic moderate to severe mitral regurgitation. This trial evaluates how well the device can replace the diseased mitral valve using a minimally invasive approach. The study is sponsored by Tioga Cardiovascular, Inc.

Who may be eligible for this mitral regurgitation clinical trial?

Adults aged 18 years or older with symptomatic moderate to severe mitral regurgitation may be eligible. Participants should have a heart team decision that surgery or other treatments are not suitable. Both males and females can join, but pregnant or breastfeeding women cannot participate. Please review eligibility criteria for more details.

Is there any cost to participate in this mitral regurgitation clinical trial?

Study-related care, including the device implant and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06038838

Assessing Safety and Feasibility of the Tioga TMVR System to Treat Moderate to Severe Mitral Regurgitation in Adults

Led by Tioga Cardiovascular, Inc. · Updated on 2025-11-12

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and feasibility of the Tioga TMVR System for treating patients with symptomatic mitral regurgitation MR of moderate to severe degree MR 3. This prospective, single-arm, multi-center study plans to enroll up to 30 patients, focusing on those who are not ideal candidates for surgical intervention or other treatments. The Tioga TMVR System is designed to replace the native mitral valve through a minimally invasive, percutaneous transseptal approach. The investigational device involves implanting a bioprosthetic mitral valve via transfemoral-transseptal access to replace the diseased valve. All participants receive treatment with the Tioga TMVR System as part of a single study group. The study includes the index procedure on Day 0 and monitors participants closely for safety and performance outcomes during the early post-procedure period. Participants will undergo follow-up visits to assess safety up to 30 days after the procedure and performance outcomes immediately after the valve replacement. Researchers will monitor heart function and related health parameters, track any adverse events, and evaluate how well the device works in replacing the mitral valve. The total study duration includes initial treatment and follow-up assessments to ensure thorough evaluation of the devices use in this patient population.

CONDITIONS

Brief Title

Feasibility Study of the Tioga TMVR System

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Symptomatic moderate to severe mitral regurgitation (MR grade 3+ or 4+)
New York Heart Association (NYHA) Functional Classification of II or higher
Heart team agrees patient is not ideal for surgery or other available 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 (LVEF) less than 30%
Left ventricular end-diastolic diameter (LVEDD) greater than 70 mm
Anatomic features unsuitable for the Tioga TMVR System (e.g., annular dimensions, neo-LVOT area, access issues, mitral annular calcification)
Severe aortic valve stenosis or regurgitation
Severe right ventricular dysfunction or severe tricuspid valve disease
Presence 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 before enrollment
Carotid surgery within 30 days before enrollment
Open cardiac or vascular surgery (except carotid surgery) within 90 days before enrollment
Myocardial infarction within 30 days before enrollment
Cardiac resynchronization therapy device implanted within 30 days before enrollment
History of endocarditis within 6 months before enrollment or active systemic infection or sepsis
Planned cardiovascular procedure within 30 days after enrollment
Cerebrovascular accident or transient ischemic attack within 30 days before enrollment
Active peptic ulcer or gastrointestinal bleeding within 90 days before enrollment
Cardiogenic shock or hemodynamic instability requiring inotropic or mechanical support
Pulmonary arterial hypertension with fixed pulmonary artery systolic pressure above 70 mmHg or pulmonary vascular resistance above 5 Wood units not reduced by vasodilators
Severe chronic obstructive pulmonary disease or airways disease requiring continuous home oxygen
Renal insufficiency with eGFR less than 20 mL/min or end-stage renal disease on dialysis
Life expectancy less than 12 months
On waiting list for heart transplant or prior heart transplant
Child-Pugh class C cirrhosis
Blood disorders defined by acute anemia with hemoglobin less than 9, platelets less than 75,000, or white blood cells less than 0.5
Female who is breastfeeding, pregnant, or planning pregnancy during the study
Known hypersensitivity or contraindication to procedural or post-procedural medications or to nickel or titanium
Inability to tolerate anticoagulation or antiplatelet therapies

Research Team

Mariam Maghribi

Tom Kelly

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Assessing Safety and Feasibility of the Tioga TMVR System to Treat Moderate to Severe Mitral Regurgitation in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria