Mitral RegurgitationNCT06038838
Feasibility Study of the Tioga TMVR System
A study testing Tioga TMVR System in people with Mitral Regurgitation, run by Tioga Cardiovascular, Inc. at 5 sites in 4 countries.
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+) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Tioga TMVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Apr 2024to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Georgia2 sites, 2 recruiting
- Recruiting
Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)
Tbilisi
Dr Salome, salofifo@gmail.com
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi
Dr Ketevan Gabunia, kgabunia@tbhc.ge
Brazil1 site, 1 recruiting
- Recruiting
Incor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo
John Papazian, john.victorpapazian@hc.fm.usp.br
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius Univ. Hospital
Vilnius
Eglė Urbonaite, egle.urbonaite@santa.lt
Paraguay1 site, 1 recruiting
- Recruiting
Sanatorio Italiano
Asunción
Alvaro Cardenas, +595 983 788003
About this study
Official title: 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+)
Read the 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+).
- Conditions
- Mitral Regurgitation
- Being tested
- Tioga TMVR System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Symptomatic MR (MR>=3+) | Experimental | Subjects treated with the Tioga TMVR System Receives: Device: Tioga TMVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At completion of index procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Apr 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tioga Cardiovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038838
- Sponsor's protocol ID
- CP-03218
- Status last verified
- Nov 2025
- First submitted
- 30 Aug 2023
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT06038838
- Acronym / sponsor ID
- CP-03218
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tioga Cardiovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Symptomatic MR (MR>=3+) | Experimental | Device: Tioga TMVR SystemSubjects treated with the Tioga TMVR System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tioga TMVR SystemA bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access. | Device | Patients with Symptomatic MR (MR>=3+) |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tioga TMVR System in people with Mitral Regurgitation, run by Tioga Cardiovascular, Inc. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Georgia, Brazil, Lithuania, Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Maghribi (510-705-2569, mariam@tiogamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: From index procedure (Day 0) to 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.