NCT06038838

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+)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2024Jul 2028

First Submitted

Initial submission to the registry

August 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

August 30, 2023

Last Update Submit

November 7, 2025

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

Patients with Symptomatic MR (MR>=3+)

EXPERIMENTAL

Subjects treated with the Tioga TMVR System

Device: Tioga TMVR System

Interventions

Tioga TMVR SystemDEVICE

A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.

Patients with Symptomatic MR (MR>=3+)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Incor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, Brazil

RECRUITING

Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)

Tbilisi, Georgia

RECRUITING

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

RECRUITING

Vilnius Univ. Hospital

Vilnius, Lithuania

RECRUITING

Sanatorio Italiano

Asunción, Paraguay

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Mariam Maghribi

CONTACT

510-705-2569mariam@tiogamed.com

Tom Kelly

CONTACT

510-304-1117tkelly@tiogamed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 15, 2023

Study Start

April 1, 2024

Primary Completion

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Last Updated

November 12, 2025

Record last verified: 2025-11

Locations

BR(1)GE(2)PA(1)LI(1)