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Transcatheter Treatment of Tricuspid Valve Regurgitation

Primary Purpose

Symptomatic Severe Tricuspid Regurgitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TriFlo Tricuspid Flow Optimizer
Sponsored by
TriFlo Cardiovascular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Severe Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pineta Grande Hospital
  • IRCCS Humanitas Research Hospital
  • IRCCS Policlinico San Donato
  • Policlinico Campus Biomedico

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm

Arm Description

Single-arm: subjects with Tricuspid valve regurgitation who meet the study eligibility criteria

Outcomes

Primary Outcome Measures

Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
a composite of death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TFO implantation, bleeding).

Secondary Outcome Measures

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
TriFlo Cardiovascular, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06093828
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2024 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriFlo Cardiovascular, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Severe Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a prospective single-arm, multicenter pre-market study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-arm
Arm Type
Other
Arm Description
Single-arm: subjects with Tricuspid valve regurgitation who meet the study eligibility criteria
Intervention Type
Device
Intervention Name(s)
TriFlo Tricuspid Flow Optimizer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
Description
a composite of death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TFO implantation, bleeding).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Tocchi, MD
Phone
+39 06 45429780
Email
m.tocchi@meditrial.eu
Facility Information:
Facility Name
Pineta Grande Hospital
City
Castel Volturno
State/Province
Caserta
ZIP/Postal Code
81030
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Giordano, Dr.
Facility Name
IRCCS Humanitas Research Hospital
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Mangieri, Dr.
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Bedogni, Dr.
Facility Name
Policlinico Campus Biomedico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Grigioni, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcatheter Treatment of Tricuspid Valve Regurgitation

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