Feasibility Study of the Tioga TMVR System

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06038838
• Other study ID #: CP-03218
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: September 2023
• Source: Tioga Cardiovascular, Inc.
• Contact: Andrew Fu
• Phone: (408) 560-2500
• Email: andrew.fu[@]tiogamed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tioga Cardiovascular, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)