Feasibility Study of the Tioga TMVR System

Tioga Cardiovascular

Status: Not yet enrolling

Conditions: Mitral Regurgitation

Treatments: Device: Tioga TMVR System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06038838

CP-03218

Details and patient eligibility

About

The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)

Full 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+).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with Symptomatic MR (MR>=3+)

Experimental group

Description:

Subjects treated with the Tioga TMVR System

Treatment:

Device: Tioga TMVR System