Symptomatic Severe Tricuspid RegurgitationNCT06093828
Transcatheter Treatment of Tricuspid Valve Regurgitation
A study testing TriFlo Tricuspid Flow Optimizer in people with Symptomatic Severe Tricuspid Regurgitation, run by TriFlo Cardiovascular, Inc. at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Severe Tricuspid Regurgitation
- What is being tested?
- TriFlo Tricuspid Flow Optimizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesItaly
- Study dates
- Oct 2024to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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.
- 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
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites
Pineta Grande Hospital
Castel Volturno, Caserta, 81030
Arturo Giordano, Dr.
Policlinico Campus Biomedico
Roma, 00128
Francesco Grigioni, Prof.
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089
Antonio Mangieri, Dr.
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Francesco Bedogni, Dr.
About this study
Official title: Transcatheter Treatment of Tricuspid Valve Regurgitation With the TriFlo Tricuspid Flow Optimizer (TFO) System
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.
Read 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 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.
- Being tested
- TriFlo Tricuspid Flow Optimizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriFlo Tricuspid Flow OptimizerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | Single-arm: subjects with Tricuspid valve regurgitation who meet the study eligibility criteria Receives: Device: TriFlo Tricuspid Flow Optimizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startOct 2024 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Severe Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective single-arm, multicenter pre-market study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriFlo Cardiovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093828
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Treatment of Tricuspid Valve Regurgitation With the TriFlo Tricuspid Flow Optimizer (TFO) System
- ClinicalTrials.gov ID
- NCT06093828
- Acronym / sponsor ID
- CIP-001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TriFlo Cardiovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective single-arm, multicenter pre-market study.
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Device: TriFlo Tricuspid Flow OptimizerSingle-arm: subjects with Tricuspid valve regurgitation who meet the study eligibility criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (29 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriFlo Tricuspid Flow OptimizerAn 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. | Device | Single-arm |
Primary outcome
Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE)
Time frame: 30 days
a composite of death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed TFO implantation, bleeding).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Severe Tricuspid Regurgitation
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Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
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Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Recruiting
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
Severe Tricuspid Regurgitation
Recruiting
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Tricuspid Valve Regurgitation, Tricuspid Valve Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriFlo Tricuspid Flow Optimizer in people with Symptomatic Severe Tricuspid Regurgitation, run by TriFlo Cardiovascular, Inc. at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Tocchi, MD (+39 06 45429780, m.tocchi@meditrial.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute safety, defined as freedom from device- or procedure-related Major Adverse Events (MAE) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.