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Feasibility Study of the Tioga TMVR System

Sponsor
Tioga Cardiovascular, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06038838
Collaborator
(none)
30
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

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+)

Condition or Disease Intervention/Treatment Phase
  • Device: Tioga TMVR System
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tioga Cardiovascular, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tioga Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT06038838
Other Study ID Numbers:
  • CP-03218
First Posted:
Sep 15, 2023
Last Update Posted:
Sep 15, 2023
Last Verified:
Sep 1, 2023
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
Additional relevant MeSH terms:
Mitral Valve Insufficiency

Study Results

No Results Posted as of Sep 15, 2023