Status:
NOT_YET_RECRUITING
Transcatheter Treatment of Tricuspid Valve Regurgitation
Lead Sponsor:
TriFlo Cardiovascular, Inc.
Conditions:
Symptomatic Severe Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tricuspid Regurgitation induces an asymmetric enlargement of the tricuspid valve (TV) annulus causing a reduction of leaflets coaptation. Annular dilation continues even after surgical treatment. The ...
Detailed Description
This study is a prospective single-arm, multicenter pre-market study. Recent epidemiological data estimate the prevalence of significant tricuspid regurgitation (TR) in the general population to be as...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Symptomatic severe tricuspid regurgitation 3+ on a scale of 0+ to 5+, according to semi-quantitative echocardiographic color flow doppler evaluation
- Tricuspid valve (TV) morphology which fulfills anatomic criteria of eligibility for the device according to Imaging Core Lab assessment
- Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related procedure
- Available and able to return to the study site for post-procedural follow-up examination
Exclusion
- CARDIOVASCULAR EXCLUSION CRITERIA
- Requirement for an interventional percutaneous procedure or cardiac surgical procedure \<30 days before or after index procedure
- Prior tricuspid repair or replacement, implantation of an artificial heart valve.
- Active endocarditis or history of endocarditis within the previous 12 months.
- Left Ventricular Ejection Fraction \<30%
- Severe aortic and mitral stenosis and/or regurgitation
- Severe tricuspid valve stenosis
- Severe right ventricular failure
- Systolic Pulmonary Artery pressure \>70 mmHg
- Echocardiographic evidence of intracardiac mass, thrombus, tumor, myxoma or vegetation
- Femoral vein, inferior vena cava or evidence of intracardiac thrombus not adequately treated
- Presence of an occluded or thrombosed inferior vena cava (IVC) filter that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis is present.
- Trans-tricuspid Pacemaker leads implanted within 90 days before the index procedure.
- EXCLUSION DUE TO COMORBIDITIES
- Cerebrovascular event within the previous 6 months.
- Myocardial infarction within 30 days prior to enrollment.
- Bleeding disorders or hypercoagulable state, thrombocytopenia (platelet count \<100,000/mm3), thrombocytosis (\>750,000/mm3) or patient who refuses blood transfusions.
- Acute anemia Hb\<8 g/dl not adequately treated or white blood cell count\<1000.
- Severe renal failure requiring chronic dialysis or eGFR\<25.
- Severe Liver disfunction - class C cirrhosis.
- Severe CLD with oxygen dependent COPD.
- Coronary artery disease requiring revascularization
- EXCLUSION DUE TO CONTRAINDICATIONS
- Unable to undergo transesophageal echocardiogram (TEE) and cardiac computed tomography (CT) or screening TEE is unsuccessful.
- Contraindication, hypersensitivity or known allergy to device's components (nickel or titanium), aspirin, anti-coagulation and antiplatelet therapy or contrast media that cannot be adequately pre-medicated.
- Known intolerance to anti-coagulation treatments.
- GENERAL EXCLUSION CRITERIA
- Female patient pregnant (urine HCG test result positive) or lactating.
- Known alcohol or drug abuser.
- Currently participating in the study of an investigational drug or device.
- Neoplasia with Life expectancy \< 12 months
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06093828
Start Date
October 1 2024
End Date
December 1 2031
Last Update
October 23 2023
Active Locations (4)
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1
Pineta Grande Hospital
Castel Volturno, Caserta, Italy, 81030
2
IRCCS Humanitas Research Hospital
Rozzano, Milano, Italy, 20089
3
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
4
Policlinico Campus Biomedico
Roma, Italy, 00128