Feasibility Study of the Tioga TMVR System

Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: Tioga TMVR System

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+).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Fu; Phone Number: (408) 560-2500; Email: andrew.fu@tiogamed.com
• Study Contact Backup: Name: Louisa Wright; Phone Number: (408) 560-2500; Email: louisa@tiogamed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Symptomatic MR (MR>=3+); Subjects treated with the Tioga TMVR System	Device: Tioga 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure	From index procedure (Day 0) to 30 days post-procedure
Primary Performance Endpoint	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	At completion of index procedure (Day 0)

Collaborators and Investigators

• Sponsor: Tioga Cardiovascular, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CP-03218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes