Tricuspid Valve DiseaseTRICAV-IINCT06458907
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
A study testing TricValve System and Optimal medical therapy in people with Tricuspid Valve Disease and Heart Valve Diseases, run by P+F Products + Features USA Inc. at 34 sites in United States.
Trial summary
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases
- What is being tested?
- TricValve System and Optimal medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 34 sitesUnited States
- Study dates
- Oct 2026to Nov 2032
- Phase
- Interventional
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 85 years old, at the time of signing the informed consent.
- Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.
- NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
- Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.
- High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.
- Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening/baseline data and imaging core lab measurements by Central Screening Committee.
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- For females of childbearing potential, negative pregnancy test.
- Capable and willing to provide signed informed consent
- Age > 85 years.
- NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.
- LVEF ≤ 30% on echocardiography.
- Severe RV dysfunction.
- Severe pulmonary hypertension (PH), defined as Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or mean Pulmonary Artery Pressure (mPAP >35) by right heart catheterization.
- Renal insufficiency: eGFR between 25 and 30 mL/min/ 1.73 m² or on chronic renal replacement therapy.
- Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.
- Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #23.
- Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).
Who cannot join
- CONCOMITANT PROCEDURES
- Patient 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 TricValve implantation.
- Patient 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 valve correction.
- CARDIOVASCULAR CONDITIONS
- LVEF ≤ 30% on echocardiography.
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
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- 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 the TricValve procedure.
- Hemodynamically significant pericardial effusion.
- Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
- Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure).
- Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.
- ALLERGIES / INTOLERANCE
- 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
- COMORBIDITIES
- Any known life-threatening condition with an estimated life span of less than 12 months.
- Platelet count < 75,000/mm3
- Child-Pugh Severity Class C (10-15 points).
- Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 30 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 100 meters in a 6-minute walk test.
- Known bleeding or clotting disorders or patient refuses blood transfusion.
- Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.
- Prior Malignancy: this study excludes participants at material risk of near-term cancer-related morbidity/mortality that could confound 12-month outcomes. This study allows the inclusion of fully treated, remote malignancies with documented No Evidence of Disease (NED)" criteria
- History of any malignancy within 5 years prior to randomization or any active malignancy, except: i. Adequately treated non-melanoma skin cancer (basal or squamous cell) with no evidence of disease, or ii. Carcinoma in situ (e.g., cervical, breast DCIS) treated with curative intent and no evidence of disease.
- Participants with a prior malignancy diagnosed >5 years before randomization are eligible if they meet all of the "No Evidence of Disease (NED)" criteria as specified below: i. No signs/symptoms of cancer on history and physical exam per standard of care; ii. No radiologic evidence of disease on surveillance imaging if such imaging is routinely indicated for that tumor type (not protocol-mandated); iii. Tumor markers (if applicable for that cancer) not suggestive of recurrence (e.g., stable/undetectable within site's lab reference and oncologist's judgment); iv. No active anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, radiotherapy) and none planned; v. Treating oncologist's attestation (or primary physician if oncology follow-up is complete) that the participant is disease-free and appropriate for participation.
- GENERAL EXCLUSIONS
- Use or participation in other investigational device or drug study in which the 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 the 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 subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Eligibility Criteria for Single Arm Cohort:
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
United States34 sites
University of Alabama
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
MUSC
Charleston, South Carolina, 29425
UVA School of Medicine
Charlottesville, Virginia, 22903
Cleveland Clinic
Cleveland, Ohio, 44106
Rishi Puri, MD
Riverside Methodist Hospital
Columbus, Ohio, 43214
Delray Medical Center
Delray Beach, Florida, 33484
Endeavor Health
Glenview, Illinois, 60026
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Taylor Gregoire, 985-873-5040 ext. 5040, taylor.gregoire@cardio.com
Peter Fail, MD
Houston Methodist
Houston, Texas, 77030
University of Texas (Memorial Hermann)
Houston, Texas, 77030
Ascension Medical Group St. Vincent The Heart Center of Indiana
Indianapolis, Indiana, 46260
University of Kansas Medical Center
Kansas City, Kansas, 66103
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
HCA Florida Largo Hospital
Largo, Florida, 33770
Saurabh Sanon, MD
Northwell Hospital
Manhasset, New York, 11030
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Intermountain Heart Institute - Intermountain Medical Center
Murray, Utah, 84107
Sentara Healthcare
Norfolk, Virginia, 23507
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Baylor Scott & White Medical
Plano, Texas, 75093
Oregon Health
Portland, Oregon, 97239
Carilion Clinic
Roanoke, Virginia, 24014
UC Davis Health
Sacramento, California, 95817
Scripps Memorial Hospital La Jolla
San Diego, California, 92037
UCSF
San Francisco, California, 94143
Kaiser Permanente
San Jose, California, 94118
Washington University of St Louis
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
MedStar Washington Hospital Center (MWHC)
Washington D.C., District of Columbia, 20010
Erin Collins
Toby Rogers, MD
About this study
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
Read the detailed description
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with severe tricuspid regurgitation and unsuitable for approved transcatheter therapies. Subjects will be followed at discharge, 1 month, 30 days, 3 months, 6 months 12 months, and annually up to 5 years.
- Conditions
- Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure, Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
- Being tested
- TricValve System, Optimal medical therapy
- Medical subject headings
- Heart Valve Diseases, Cardiovascular Diseases, Heart Failure, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TricValve SystemDevice
Also called Heterotopic caval valve implantation (CAVI)
- Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy
Optimal medical therapyDrug
Also called OMT
Optimal medical therapy
| Study group | Role | What they receive |
|---|---|---|
| TricValve System + Optimal medical therapy (OMT) | Experimental | Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation. Receives: Device: TricValve System; Drug: Optimal medical therapy |
| Optimal medical therapy (OMT) Alone | Active comparator | OMT alone in patients with caval reflux and tricuspid regurgitation Receives: Drug: Optimal medical therapy |
| TricValve Single Arm Registry | Experimental | Single-Arm Registry for Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with OMT in patients with caval reflux and tricuspid regurgitation who are not eligible for randomization Receives: Device: TricValve System; Drug: Optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomized Cohort: Caval Reflux (CR) grade reduction
Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR are better.
Measured: 6 months
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
Measured: 6 months
Randomized Cohort: Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT)
Measured: 30 days
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
Measured: 1 year
Registry Cohort: Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in single arm registry
Measured: 30 days
Secondary outcomes (18)
Randomized Cohort: Percentage of Device- and/or Procedure-related MAEs
Rate of Major Adverse Events
Measured: 1 year
Randomized Cohort: All-Cause mortality and Cardiovascular Mortality
Number of deaths from any cause as well as cardiovascular events
Measured: 6 months and 1 year
Randomized Cohort: Heart Failure Hospitalizations (HFH)
Number of Heart Failure Hospitalizations and worsening HF events without hospitilization
Measured: 6 months and 1 year
Randomized Cohort: RVAD Implantation or Heart Transplant
Number of patients requiring RVAD Implantation or Heart Transplant
Measured: 6 months and 1 year
Randomized Cohort: Atrial Fibrillation
New onset of atrial fibrillation
Measured: 1 year
Randomized Cohort: Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) .
Improvement of at least 10 points from baseline. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life (QOL)
Measured: 6 months and 1 year
Randomized Cohort: Changes in symptom status New York Heart Association (NYHA class)
Reduction of at least 1 class from baseline. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 6 months and 1 year
Randomized Cohort: Changes in functional capacity (6-minute walk test, 6MWT).
Improvement of 6-minute walk distance of at least 30 meters from baseline.
Measured: 6 months and 1 year
Registry Cohort: Heart Failure Hospitalization
Comparison of the 12-month post-procedure HFH rate with the 12-month pre-procedure rate
Measured: 1 year
Registry Cohort: Changes in Quality of life (by Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score).
Change from baseline to 12 months. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life (QOL)
Measured: 1 year
Roll-In Cohort: Percentage of Device- and/or Procedure-related MAEs
Rate of Major Adverse Events
Measured: 1 year
Roll-In Cohort: All-Cause mortality and Cardiovascular Mortality
Number of deaths from any cause as well as cardiovascular events
Measured: 6 months and 1 year
Roll-In Cohort: Heart Failure Hospitalizations (HFH)
Number of Heart Failure Hospitalizations and worsening HF events without hospitalization
Measured: 6 months and 1 year
Roll-In Cohort: RVAD Implantation or Heart Transplant
Number of patients requiring RVAD Implantation or Heart Transplant
Measured: 6 months and 1 year
Roll-In Cohort: Atrial Fibrillation
New onset of atrial fibrillation
Measured: 1 year
Roll-In Cohort: Quality of life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ).
Improvement of at least 10 points from baseline. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life
Measured: 6 months and 1 year
Roll-In Cohort: New York Heart Association (NYHA) functional class
Reduction of at least 1 class from baseline. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 6 months and 1 year
Roll-In Cohort: 6-minute walk test (6MWT).
Improvement of 6-minute walk distance of at least 30 meters from baseline.
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startOct 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- P+F Products + Features USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458907
- Sponsor's protocol ID
- CTP-TRIC-005-II
- Acronym
- TRICAV-II
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Amat-Santos IJ, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Blasco-Turrion S, Sanchez-Luna JP, Revilla-Orodoea A, Redondo A, Zamorano JL, Puri R, Iniguez-Romo A, San Roman A. Right heart remodelling after bicaval TricValve implantation in patients with severe tricuspid regurgitation. EuroIntervention. 2023 Aug 7;19(5):e450-e452. doi: 10.4244/EIJ-D-23-00077. No abstract available.
PubMed 37083622Blasco-Turrion S, Briedis K, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Sanchez-Luna JP, Gonzalez-Gutierrez JC, Revilla-Orodoea A, Zamorano JL, Gomez-Salvador I, Puri R, San Roman JA, Amat-Santos IJ. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv. 2024 Jan 8;17(1):60-72. doi: 10.1016/j.jcin.2023.10.043. Epub 2023 Dec 6.
PubMed 38069986