Feasibility Study of the Tioga TMVR System

November 7, 2025 updated by: Tioga Cardiovascular, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil
  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Tbilisi Heart And Vascular Clinic
        • Contact:
      • Tbilisi, Georgia
        • Recruiting
        • Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)
        • Contact:
  • Lithuania
  • Paraguay
      • Asunción, Paraguay
        • Recruiting
        • Sanatorio Italiano
        • Contact:
          • Alvaro Cardenas
          • Phone Number: +595 983 788003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 the subject is non-ideal for 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 < 30%
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 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
From index procedure (Day 0) to 30 days post-procedure
Primary Performance Endpoint
Time Frame: 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
At completion of index procedure (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tioga Cardiovascular, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP-03218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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