Mitral Regurgitation
Conditions
Brief summary
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)
Detailed description
The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously replace a patient's diseased native mitral valve with a bioprosthetic valve. The investigational device is intended for transseptal replacement of the mitral valve in patients with symptomatic MR (MR\>=3+).
Interventions
DEVICETioga TMVR System
A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.
Sponsors
Tioga Cardiovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | From index procedure (Day 0) to 30 days post-procedure | Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure |
| Primary Performance Endpoint | At completion of index procedure (Day 0) | Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab: * Absence of procedural mortality * Successful access, delivery, and retrieval of the device delivery system * Successful deployment and correct positioning of the first intended device * Freedom from emergency surgery or reintervention related to the device or access procedure |
Countries
Brazil, Georgia, Lithuania, Paraguay
Contacts
Primary ContactMariam Maghribi
Backup ContactTom Kelly
Outcome results
None listed