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New treatment option for Tricuspid Regurgitation
Official title TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
ClinicalTrials.gov ID: NCT06137807
What this study is testing
- What it's testing
- The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be 18 years or older, at the time of signing the informed consent.
- people has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography...
- NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
- Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index...
- The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
You likely can't join if
- Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention...
- Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis...
- LVEF ≤ 30% on echocardiography.
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 [at least 0.75 if BMI \>30 kg/m2], DVI \<2.2, mean...
- Severe right ventricular dysfunction.
See the full eligibility criteria
Who can join
- Subject must be 18 years or older, at the time of signing the informed consent.
- people has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
- NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
- Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.
- The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
- For females of childbearing potential, negative pregnancy test.
- Capable of giving signed informed consent.
What rules you out
- Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to...
- Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary...
- LVEF ≤ 30% on echocardiography.
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 [at least 0.75 if BMI \>30 kg/m2], DVI \<2.2, mean gradient \<5mm Hg); reduction of total tricuspid regurgitation to...
- Severe right ventricular dysfunction.
- Cardiac amyloidosis
- Pulmonary artery systolic pressure (PASP) \>65 mmHg assessed with Echo Doppler and /or right heart catheterization.
- Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
- Hemodynamically significant pericardial effusion.
- Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
- Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
- Unable to tolerate anticoagulation/antiplatelet therapy
- Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
- Any known life-threatening condition with an estimated life span of at least 12 months.
- Platelet count \< 75,000/mm3
- Child-Pugh Severity Class C (10-15 points).
- Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
- Endocarditis or active/ongoing infection requiring antibiotics.
- Unable to walk at least 60 meters in a 6minute walk test.
- Known bleeding or clotting disorders or patient refuses blood transfusion.
- Active gastrointestinal (GI) bleeding within 3 months of randomization.
- Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
- Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.
- Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.
- Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
- Pregnant or breastfeeding people and those who plan pregnancy during the clinical investigation follow-up period.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- San Diego, California, United States
- San Francisco, California, United States
- Delray Beach, Florida, United States
- Largo, Florida, United States
- Tampa, Florida, United States
- Glenview, Illinois, United States
- Palos Park, Illinois, United States
- Indianapolis, Indiana, United States
- Houma, Louisiana, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Manhasset, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
+ 14 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; San Diego, California, United States; San Francisco, California, United States; Delray Beach, Florida, United States; Largo, Florida, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.