Clinical trial NCT06093828: Transcatheter Treatment of Tricuspid Valve Regurgitation
Official title: Transcatheter Treatment of Tricuspid Valve Regurgitation With the TriFlo Tricuspid Flow Optimizer (TFO) System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Symptomatic Severe Tricuspid Regurgitation
Lead sponsor: TriFlo Cardiovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective single-arm, multicenter pre-market study.
Primary purpose: TREATMENT

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 progressive nature of TR, inadequate surgical treatment, and high-risk patient population make TR an ideal target for transcatheter therapy. The TriFlo TFO System introduces a new concept for the treatment of tricuspid regurgitation. Its commissural anchoring is designed to respect TV leaflet integrity, mobility, and maintain RV contractility.

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 high as 0.55% (and up to 3% after 75 years of age), a prevalence comparable to aortic stenosis (AS) or mitral regurgitation (MR). Although the prevalence is high, TR is often not treated. In the United States, approximately 1.6 million patients live with moderate to severe TR, and fewer than 8,000 tricuspid surgeries are performed annually.

Clinically relevant TR is present in approximately 3.0 million individuals in Europe and 70 million people worldwide. Approximately 90% of TR in adults is functional (secondary) and can be due to left-sided myocardial or valvular disease, pulmonary vascular disease, right ventricular myopathy,chronic right ventricular volume overload, or idiopathic. Uncertainty about the impact of TR on outcomes is related to the heterogeneous nature of the tricuspid disease, which is often secondary to other conditions (mainly left-sided disease or pulmonary hypertension). In spite of its high prevalence, tricuspid valve disease is a largely untreated condition and is known to be associated with poor life expectancy.

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the TriFlo Tricuspid Flow Optimizer in the treatment of severe TR.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Symptomatic severe tricuspid regurgitation 3+ on a scale of 0+ to 5+, according to semi-quantitative echocardiographic color flow doppler evaluation
3. Tricuspid valve (TV) morphology which fulfills anatomic criteria of eligibility for the device according to Imaging Core Lab assessment
4. Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related procedure
5. Available and able to return to the study site for post-procedural follow-up examination

Exclusion Criteria:

CARDIOVASCULAR EXCLUSION CRITERIA

1. Requirement for an interventional percutaneous procedure or cardiac surgical procedure \<30 days before or after index procedure
2. Prior tricuspid repair or replacement, implantation of an artificial heart valve.
3. Active endocarditis or history of endocarditis within the previous 12 months.
4. Left Ventricular Ejection Fraction \<30%
5. Severe aortic and mitral stenosis and/or regurgitation
6. Severe tricuspid valve stenosis
7. Severe right ventricular failure
8. Systolic Pulmonary Artery pressure \>70 mmHg
9. Echocardiographic evidence of intracardiac mass, thrombus, tumor, myxoma or vegetation
10. Femoral vein, inferior vena cava or evidence of intracardiac thrombus not adequately treated
11. 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.
12. Trans-tricuspid Pacemaker leads implanted within 90 days before the index procedure.

    EXCLUSION DUE TO COMORBIDITIES
13. Cerebrovascular event within the previous 6 months.
14. Myocardial infarction within 30 days prior to enrollment.
15. Bleeding disorders or hypercoagulable state, thrombocytopenia (platelet count \<100,000/mm3), thrombocytosis (\>750,000/mm3) or patient who refuses blood transfusions.
16. Acute anemia Hb\<8 g/dl not adequately treated or white blood cell count\<1000.
17. Severe renal failure requiring chronic dialysis or eGFR\<25.
18. Severe Liver disfunction - class C cirrhosis.
19. Severe CLD with oxygen dependent COPD.
20. Coronary artery disease requiring revascularization

    EXCLUSION DUE TO CONTRAINDICATIONS
21. Unable to undergo transesophageal echocardiogram (TEE) and cardiac computed tomography (CT) or screening TEE is unsuccessful.
22. 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.
23. Known intolerance to anti-coagulation treatments.

    GENERAL EXCLUSION CRITERIA
24. Female patient pregnant (urine HCG test result positive) or lactating.
25. Known alcohol or drug abuser.
26. Currently participating in the study of an investigational drug or device.
27. Neoplasia with Life expectancy \< 12 months

Primary outcomes:
measure: Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Castel Volturno
country: Italy
facility: Pineta Grande Hospital
state: Caserta
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: Milano
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
city: Roma
country: Italy
facility: Policlinico Campus Biomedico
Study officials:
References: