Pivotal Trial to Evaluate the Safety and Effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System (TRICAV-II)

A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.

Pivotal trial to evaluate the safety and effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Heart Failure; Heart Valve Diseases; Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease
• Intervention / Treatment: Drug: Optimal medical therapy; Device: TricValve System

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.

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thuy Olender; Phone Number: +1 408-839-3809; Email: tolender@productsandfeatures.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Health
    • San Diego, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • San Francisco, California, United States, 94143
      • UCSF
    • San Jose, California, United States, 94118
      • Kaiser Permanente
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Largo, Florida, United States, 33770
      • HCA Florida Largo Hospital
      • Principal Investigator: Saurabh Sanon, MD
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Endeavor Health
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ascension Medical Group St. Vincent The Heart Center of Indiana
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital & Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Mid America Heart Institute
    • St Louis, Missouri, United States, 63110
      • Washington University of St Louis
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Hospital
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic
      • Principal Investigator: Rishi Puri, MD
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17107
      • UPMC Pinnacle
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States, 77030
      • University of Texas (Memorial Hermann)
    • Plano, Texas, United States, 75093
      • Baylor Scott & White Medical
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Heart Institute - Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA School of Medicine
    • Norfolk, Virginia, United States, 23507
      • Sentara Healthcare
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • Washington
    • Multiple Locations, Washington, United States, 20010
      • Medstar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria for Randomized Cohort:

Inclusion Criteria:

1. Age between 18 years and 85 years old, at the time of signing the informed consent.
2. 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.
3. NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
4. 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.
5. High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.
6. 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.
7. For females of childbearing potential, negative pregnancy test.
8. Capable and willing to provide signed informed consent

Exclusion Criteria:

CONCOMITANT PROCEDURES

1. 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.

2. 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

3. LVEF ≤ 30% on echocardiography.
4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
5. Severe right ventricular dysfunction.
6. Cardiac amyloidosis.
7. Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.
8. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to the TricValve procedure.
9. Hemodynamically significant pericardial effusion.
10. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure).

12. 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

13. Any known allergy or hypersensitivity to nitinol, bovine tissue, or contrast media that cannot be adequately treated with pre-medication.

14. Unable to tolerate anticoagulation/antiplatelet therapy

    COMORBIDITIES

15. Any known life-threatening condition with an estimated life span of less than 12 months.
16. Platelet count < 75,000/mm3
17. Child-Pugh Severity Class C (10-15 points).
18. 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.
19. Endocarditis or active/ongoing infection requiring antibiotics.
20. Unable to walk at least 100 meters in a 6-minute walk test.
21. Known bleeding or clotting disorders or patient refuses blood transfusion.
22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.

23. 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

    a. 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.

    b. 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

24. 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.
25. Any other condition that would preclude the ability to meet study requirements in the opinion of the investigator.
26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.

Eligibility Criteria for Single Arm Cohort:

Inclusion Criteria:

1. Age > 85 years.
2. NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.
3. LVEF ≤ 30% on echocardiography.
4. Severe RV dysfunction.
5. 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.
6. Renal insufficiency: eGFR between 25 and 30 mL/min/ 1.73 m² or on chronic renal replacement therapy.
7. Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.
8. Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #23.
9. Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TricValve System + Optimal medical therapy (OMT); Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation.	Drug: Optimal medical therapy; Optimal medical therapy; Other Names: OMT; Device: TricValve System; • Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy; Other Names: Heterotopic caval valve implantation (CAVI)
Active Comparator: Optimal medical therapy (OMT) Alone; OMT alone in patients with caval reflux and tricuspid regurgitation	Drug: Optimal medical therapy; Optimal medical therapy; Other Names: OMT
Experimental: TricValve Single Arm Registry; 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	Drug: Optimal medical therapy; Optimal medical therapy; Other Names: OMT; Device: TricValve System; • Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy; Other Names: Heterotopic caval valve implantation (CAVI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Cohort: Percentage of Device- and/or Procedure-related MAEs	Rate of Major Adverse Events	1 year
Randomized Cohort: All-Cause mortality and Cardiovascular Mortality	Number of deaths from any cause as well as cardiovascular events	6 months and 1 year
Randomized Cohort: Heart Failure Hospitalizations (HFH)	Number of Heart Failure Hospitalizations and worsening HF events without hospitilization	6 months and 1 year
Randomized Cohort: RVAD Implantation or Heart Transplant	Number of patients requiring RVAD Implantation or Heart Transplant	6 months and 1 year
Randomized Cohort: Atrial Fibrillation	New onset of atrial fibrillation	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)	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).	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.	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	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)	1 year
Roll-In Cohort: Percentage of Device- and/or Procedure-related MAEs	Rate of Major Adverse Events	1 year
Roll-In Cohort: All-Cause mortality and Cardiovascular Mortality	Number of deaths from any cause as well as cardiovascular events	6 months and 1 year
Roll-In Cohort: Heart Failure Hospitalizations (HFH)	Number of Heart Failure Hospitalizations and worsening HF events without hospitalization	6 months and 1 year
Roll-In Cohort: RVAD Implantation or Heart Transplant	Number of patients requiring RVAD Implantation or Heart Transplant	6 months and 1 year
Roll-In Cohort: Atrial Fibrillation	New onset of atrial fibrillation	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	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).	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.	6 months and 1 year

Collaborators and Investigators

• Sponsor: P+F Products + Features USA Inc.
• Collaborators: Meditrial USA Inc.

Publications and helpful links

General 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.
• Blasco-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.

Helpful Links

• Meditrial Clinical Research Organization
• Products & Features, manufacturer of TricValve® Transcatheter Bicaval Valve System

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Tricuspid Regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Heart Failure; Cardiovascular Diseases; Tricuspid Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: CTP-TRIC-005-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes