Feasibility Study of the Tioga TMVR System
- Conditions
- Mitral Regurgitation
- Interventions
- Device: Tioga TMVR System
- Registration Number
- NCT06038838
- Lead Sponsor
- Tioga Cardiovascular, Inc.
- 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+).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age 18 years or older
- Symptomatic, moderate to severe (3+) or severe (4+) MR
- NYHA Functional Classification ≥ II
- Heart team concurs that TMVR is the preferred treatment over 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
- LVEF < 25%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with Symptomatic MR (MR>=3+) Tioga TMVR System Subjects treated with the Tioga TMVR System
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method