A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
TRICAV-II
1 other identifier
interventional
780
1 country
35
Brief Summary
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2032
July 9, 2026
July 1, 2026
2.3 years
June 7, 2024
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
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.
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.
6 months
Randomized Cohort: Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT)
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.
1 year
Registry Cohort: Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in single arm registry
30 days
Secondary Outcomes (18)
Randomized Cohort: Percentage of Device- and/or Procedure-related MAEs
1 year
Randomized Cohort: All-Cause mortality and Cardiovascular Mortality
6 months and 1 year
Randomized Cohort: Heart Failure Hospitalizations (HFH)
6 months and 1 year
Randomized Cohort: RVAD Implantation or Heart Transplant
6 months and 1 year
Randomized Cohort: Atrial Fibrillation
1 year
- +13 more secondary outcomes
Study Arms (3)
TricValve System + Optimal medical therapy (OMT)
EXPERIMENTALHeterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation.
Optimal medical therapy (OMT) Alone
ACTIVE COMPARATOROMT alone in patients with caval reflux and tricuspid regurgitation
TricValve Single Arm Registry
EXPERIMENTALSingle-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
Interventions
Optimal medical therapy
• Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy
Eligibility Criteria
You may qualify if:
- 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.
- For females of childbearing potential, negative pregnancy test.
- Capable and willing to provide signed informed consent
You may not qualify if:
- 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.
- 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
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- P+F Products + Features USA Inc.lead
- Meditrial USA Inc.collaborator
Study Sites (35)
University of Alabama
Birmingham, Alabama, 35233, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
UC Davis Health
Sacramento, California, 95817, United States
Scripps Memorial Hospital La Jolla
San Diego, California, 92037, United States
UCSF
San Francisco, California, 94143, United States
Kaiser Permanente
San Jose, California, 94118, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
HCA Florida Largo Hospital
Largo, Florida, 33770, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Endeavor Health
Glenview, Illinois, 60026, United States
Ascension Medical Group St. Vincent The Heart Center of Indiana
Indianapolis, Indiana, 46260, United States
University of Kansas Medical Center
Kansas City, Kansas, 66103, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111, United States
Washington University of St Louis
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Northwell Hospital
Manhasset, New York, 11030, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oregon Health
Portland, Oregon, 97239, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, 17107, United States
MUSC
Charleston, South Carolina, 29425, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Texas (Memorial Hermann)
Houston, Texas, 77030, United States
Baylor Scott & White Medical
Plano, Texas, 75093, United States
Intermountain Heart Institute - Intermountain Medical Center
Murray, Utah, 84107, United States
UVA School of Medicine
Charlottesville, Virginia, 22903, United States
Sentara Healthcare
Norfolk, Virginia, 23507, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
MedStar Washington Hospital Center
Multiple Locations, Washington, 20010, United States
Related Publications (2)
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.
PMID: 37083622BACKGROUNDBlasco-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.
PMID: 38069986RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 14, 2024
Study Start
August 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2032
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share