TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) (TRICAV-I)

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

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. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation; Tricuspid Valve Disease
• Intervention / Treatment: Device: TricValve® Transcatheter Bicaval Valve System

Detailed Description

This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery.

Patients who meet all of the study inclusion criteria, will be treated with the TricValve System. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Tocchi, MD, PhD; Phone Number: 9176841700; Email: m.tocchi@meditrial.net

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • St. Joseph's Hospital and Medical Center
      • Contact: Hursh Naik
    • Tucson, Arizona, United States, 85712
      • Not yet recruiting
      • Tucson Medical Center
      • Contact: Thomas Waggoner
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • Scripps Memorial Hospital La Jolla
      • Contact: Matthew J. Price
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • UCSF
      • Contact: Sammy Elmariah
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Not yet recruiting
      • Delray Medical Center
      • Contact: Tilak Pasala
    • Largo, Florida, United States, 33770
      • Recruiting
      • Largo Medical Center
      • Contact: Saurabh Sanon
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Hiram Bezerra
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Endeavor Health, Glenbrook Hospital
      • Contact: Mark J. Ricciardi
    • Palos Park, Illinois, United States, 60464
      • Not yet recruiting
      • Chicago Advocate Christ
      • Contact: Ravi Ramana
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Ascension Medical Group St. Vincent The Heart Center of Indiana
      • Contact: James Hermiller
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Recruiting
      • Cardiovascular Institute of the South
      • Contact: Peter Fail
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Dhaval Kolte
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Roger Laham
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Lahey Hospital & Medical Center
      • Contact: Gautam Gadey
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Contact: Paul Sorajja
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Not yet recruiting
      • Saint Luke's Mid America Heart Institute
      • Contact: Adnon Chhatriwalla
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Washington University St Louis
      • Contact: Alan Zajarias
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Not yet recruiting
      • Hackensack University Medical Center
      • Contact: Ryan Kaple
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Edwin Ho
    • Manhasset, New York, United States, 11030
      • Not yet recruiting
      • North Shore University Hospital
      • Contact: Bruce Rutkin
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke Cardiology Clinic
      • Contact: Marat Fudim
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Cleveland Clinic
      • Contact: Rishi Puri, MD
    • Columbus, Ohio, United States, 43214
      • Not yet recruiting
      • Riverside Methodist Hospital
      • Contact: Carlos Sanchez
      • Contact: Steve Yakubuv
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Oregon Health Services
      • Contact: Firas Zahr
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17107
      • Recruiting
      • UPMC Pinnacle
      • Contact: Hemal Gada
    • Pittsburgh, Pennsylvania, United States, 15232
      • Not yet recruiting
      • UPMC Presbyterian Shadyside
      • Contact: Catalin Toma
    • York, Pennsylvania, United States, 17403
      • Not yet recruiting
      • Wellspan York Hospital
      • Contact: James Harvey
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • MUSC
      • Contact: Nicholas Amoroso
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist
      • Contact: Sachin Goel
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas (Memorial Hermann)
      • Contact: Biswajit Kar
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Heart Institute - Intermountain Medical Center
      • Contact: Brian Whisenant
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • UVA School of Medicine
      • Contact: John Saxon
    • Norfolk, Virginia, United States, 23507
      • Not yet recruiting
      • Sentara Healthcare
      • Contact: Matthew Summers
    • Roanoke, Virginia, United States, 24014
      • Not yet recruiting
      • Carilion Clinic
      • Contact: Jason Foerst
  • Washington
    • Multiple Locations, Washington, United States, 20010
      • Recruiting
      • Medstar Washington Hospital Center
      • Contact: Toby Rogers
    • Seattle, Washington, United States, 98122
      • Not yet recruiting
      • Swedish Medical Center
      • Contact: Sameer Gafoor

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Subject must be 18 years or older, at the time of signing the informed consent.
2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
4. 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.
5. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
6. For females of childbearing potential, negative pregnancy test.
7. Capable of giving signed informed consent.

Exclusion Criteria:

1. 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 TricValve implantation.
2. 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 valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).
3. LVEF ≤ 30% on echocardiography.
4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
5. 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 optimal (≤ mild [1+]) or acceptable (≤ moderate [2+]).
6. Severe right ventricular dysfunction.
7. Cardiac amyloidosis
8. Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.
9. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
10. Hemodynamically significant pericardial effusion.
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. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
13. Unable to tolerate anticoagulation/antiplatelet therapy
14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
15. Any known life-threatening condition with an estimated life span of at least 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) ≤ 25 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 60 meters in a 6minute walk test.
21. Known bleeding or clotting disorders or patient refuses blood transfusion.
22. Active gastrointestinal (GI) bleeding within 3 months of randomization.
23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
24. 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.
25. Any other condition that would preclude 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TricValve® Device (Device) Group; subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.

Device: TricValve® Transcatheter Bicaval Valve System; 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 system is a single use, sterile device compatible with all the valve sizes. The valves are premounted in the TricValve® Delivery System. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system available in sizes 25 and 29 for superior vena cava and 31 and 35 for inferior vena cava. The valve is implanted percutaneously by the transfemoral approach. The valves are supplied already premounted into the TricValve® Delivery System.; Other Names: TricValve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of days until death	1 Month and 12 Months
Stroke	Number of days until death	1 Month
Pulmonary Embolism	Number of days until death	1 Month
Valve Academic Research Consortium (VARC) type 2-4 bleeding complication	Number of days until death	1 Month
Major vascular, access-related, or cardiac structural complication	Number of days until death	1 Month
Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ≥4.0mg/dL (≥354 μmol/L) with an acute increase of ≥ 0.5 mg/dL (≥44 μmol/L)	Number of days from baseline until increase	7 Days
Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy	Number of days until new renal replacement therapy	1 Month
Emergency surgery or intervention related to the device/procedure complications	Number of days until emergency surgery or intervention	1 Month
Right Ventricular Assist Device (RVAD) implantation or heart transplant	Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant	12 Months
Tricuspid valve surgery or percutaneous tricuspid intervention	Number of days until tricuspid valve surgery or percutaneous tricuspid intervention	12 Months
Heart Failure Events	Number of heart failure episodes including hospitalization, or worsening heart failure	12 Months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score	Change in KCC score (score ranges between 0 and 100)	12 Months
New York Heart Association (NYHA class)	Change in NYHA class (range from I to IV)	12 Months
Six Minute Walking Test (6MWT)	Change in walking distance	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tricuspid valve surgery or percutaneous tricuspid intervention	Number of days until tricuspid valve surgery or percutaneous tricuspid intervention	12 Months
New York Heart Association (NYHA class)	Change in NYHA class (range from I to IV)	12 Months
Six Minute Walking Test (6MWT)	Change in walking distance	12 Months
Technical success of device placement (at exit from procedure room)	Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of the device into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication	Intraprocedural
Device success within 30 days after device placement	Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication	1 Month
Procedural success (at 30 days)	All of the following criteria must be met to be considered a procedural success: Device success (defined above), and; Absence of major device or procedure related serious adverse events	1 Month
Mortality	Number of days until death	12 Months
RVAD implantation or heart transplant	Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant	12 Months
Heart Failure hospitalization or worsening Heart Failure (HF) which encompasses treatment with IV diuretics in the office or Emergency Department treatment during a <24-hour time period	Number of days until Heart Failure hospitalization or worsening Heart Failure	12 Months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score	Change in KCCQ score (score ranges between 0 and 100)	12 Months

Collaborators and Investigators

• Sponsor: P+F Products + Features USA Inc.
• Collaborators: P+F Products + Features GmbH; Meditrial USA Inc.
• Investigators: Study Chair: Katharina Kiss, MD, Products & Features GmbH

Publications and helpful links

General Publications

• Estevez-Loureiro R, Sanchez-Recalde A, Amat-Santos IJ, Cruz-Gonzalez I, Baz JA, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Salido-Tahoces L, Santos-Martinez S, Nunez JC, Moris C, Goliasch G, Jimenez-Quevedo P, Ojeda S, Cid-Alvarez B, Santiago-Vacas E, Jimenez-Valero S, Serrador A, Martin-Moreiras J, Strouhal A, Hengstenberg C, Zamorano JL, Puri R, Iniguez-Romo A. 6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study. JACC Cardiovasc Interv. 2022 Jul 11;15(13):1366-1377. doi: 10.1016/j.jcin.2022.05.022. Epub 2022 May 17.
• 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.
• Abdul-Jawad Altisent O, Codina P, Puri R, Bayes-Genis A. Transcatheter bi-caval valve implantation (CAVI) significantly improves cardiac output: mechanistic insights following CardioMEMS(R) and TricValve(R) implantation. Clin Res Cardiol. 2022 Aug;111(8):966-968. doi: 10.1007/s00392-022-02029-8. Epub 2022 May 2. No abstract available.
• Chandran K, Long A, Bishop J, Berman P, Matar F, Oliveira GH, Bezerra HG. First In-Man Experience With TricValve Transcatheter Bicaval Valve System in Left Ventricular Assist Device Heartmate II Patient for High-Risk Tricuspid Regurgitation. Circ Heart Fail. 2023 Jun;16(6):e010027. doi: 10.1161/CIRCHEARTFAILURE.122.010027. Epub 2023 Jun 6. No abstract available.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset generated during and/or analysed during the study will be available upon request from the Clinical Research Organization, Meditrial USA Inc. m.tocchi@meditrial.net Datasets will only be made available through publication, unless disclosure is mandated by law.
• IPD Sharing Access Criteria: Available on request, Published as a supplement to the results publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No