- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06093828
Transcatheter Treatment of Tricuspid Valve Regurgitation
Transcatheter Treatment of Tricuspid Valve Regurgitation With the TriFlo Tricuspid Flow Optimizer (TFO) System
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Monica Tocchi, MD
- Phone Number: +39 06 45429780
- Email: m.tocchi@meditrial.eu
Study Locations
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Roma, Italy, 00128
- Policlinico Campus Biomedico
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Contact:
- Francesco Grigioni, Prof.
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Caserta
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Castel Volturno, Caserta, Italy, 81030
- Pineta Grande Hospital
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Contact:
- Arturo Giordano, Dr.
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Milano
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Rozzano, Milano, Italy, 20089
- IRCCS Humanitas Research Hospital
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Contact:
- Antonio Mangieri, Dr.
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San Donato Milanese, Milano, Italy, 20097
- IRCCS Policlinico San Donato
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Contact:
- Francesco Bedogni, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single-arm
Single-arm: subjects with Tricuspid valve regurgitation who meet the study eligibility criteria
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An introducer sheath is inserted into the femoral vein over a stiff guidewire; the sheath extends into the common iliac vein and inferior vena cava and in the right atrium.
The TFO device is oriented coaxiality to the tricuspid.
Once released, the delivery catheter and the steerable catheter are removed the access site closure performed by a cardiovascular or vascular surgeon or with pre-implanted percutaneous sutures per site preference.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
Time Frame: 30 days
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a composite of death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TFO implantation, bleeding).
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30 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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