Clinical trial NCT06038838: Feasibility Study of the Tioga TMVR System
Official title: Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Tioga Cardiovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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+).

Eligibility 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 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: From index procedure (Day 0) to 30 days post-procedure
measure: Primary Performance Endpoint
timeFrame: At completion of index procedure (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: