Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-01
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with Symptomatic MR (MR>=3+)
Subjects treated with the Tioga TMVR System
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tioga Cardiovascular, Inc.
INDUSTRY
Responsible Party
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Locations
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Incor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, , Brazil
Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, , Georgia
Vilnius Univ. Hospital
Vilnius, , Lithuania
Sanatorio Italiano
Asunción, , Paraguay
Countries
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Central Contacts
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Facility Contacts
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John Papazian
Role: primary
Dr Salome
Role: primary
Dr Ketevan Gabunia
Role: primary
Eglė Urbonaite
Role: primary
Alvaro Cardenas
Role: primary
Other Identifiers
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CP-03218
Identifier Type: -
Identifier Source: org_study_id