Transseptal mitral valve replacement using the Tioga TMVR System
Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation
The Tioga TMVR System will be tried in adults with symptomatic moderate-to-severe or severe mitral regurgitation who are not good candidates for surgery or other available treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tioga Cardiovascular, Inc. Industry-sponsored |
| Locations | 5 sites (São Paulo and 4 other locations) |
| Trial ID | NCT06038838 on ClinicalTrials.gov |
What this trial studies
This prospective, single-arm, multi-center feasibility study will enroll up to 30 patients with symptomatic MR (≥3+). Eligible patients judged by a heart team to be non-ideal for surgical mitral valve replacement or other therapies (such as TEER) will undergo transseptal percutaneous implantation of a Tioga bioprosthetic mitral valve. The device is delivered via a catheter across the interatrial septum to replace the native mitral valve. Participants will be followed at scheduled intervals to monitor procedural safety, valve performance, and clinical outcomes.
Who should consider this trial
Good fit: Adults (≥18 years) with symptomatic moderate-to-severe (3+) or severe (4+) MR, NYHA class II or higher, who are deemed by a heart team to be non-ideal candidates for surgery or other treatments and meet anatomical criteria for the device.
Not a fit: Patients with LVEF <30%, LVEDD >70 mm, unsuitable mitral anatomy, prior mitral interventions or any prosthetic heart valve, intracardiac thrombus, severe aortic or right-sided valve disease, or recent endovascular procedures are likely to be excluded or may not benefit.
Why it matters
Potential benefit: If successful, the device could provide a less-invasive option to replace the mitral valve for patients who cannot undergo surgery, potentially improving symptoms and heart function.
How similar studies have performed: Transcatheter mitral valve replacement is an emerging approach with early feasibility studies showing promising but limited results, and this program builds on that growing but still preliminary clinical experience.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
São Paulo and 4 other locations
- Incor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo, Brazil (Recruiting)
- Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore) — Tbilisi, Georgia (Recruiting)
- Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (Recruiting)
- Vilnius Univ. Hospital — Vilnius, Lithuania (Recruiting)
- Sanatorio Italiano — Asunción, Paraguay (Recruiting)
Study contacts
- Study coordinator: Mariam Maghribi
- Email: mariam@tiogamed.com
- Phone: 510-705-2569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.