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
1 other identifier
interventional
50
1 country
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
ExpectedJune 8, 2025
June 1, 2025
1.3 years
October 31, 2023
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
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 Outcomes (10)
Technical success of device placement (at exit from procedure room)
Intraprocedural
Device success within 30 days after device placement
1 Month
Procedural success (at 30 days)
1 Month
Mortality
12 Months
RVAD implantation or heart transplant
12 Months
- +5 more secondary outcomes
Study Arms (1)
TricValve® Device (Device) Group
EXPERIMENTALsubjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subject must be 18 years or older, at the time of signing the informed consent.
- Subjects 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.
You may not qualify if:
- 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.
- 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.).
- 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 optimal (≤ mild \[1+\]) or acceptable (≤ moderate \[2+\]).
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- P+F Products + Features USA Inc.lead
- P+F Products + Features GmbHcollaborator
- Meditrial USA Inc.collaborator
Study Sites (36)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
Scripps Memorial Hospital La Jolla
San Diego, California, 92037, United States
UCSF
San Francisco, California, 94143, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Largo Medical Center
Largo, Florida, 33770, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Endeavor Health, Glenbrook Hospital
Glenview, Illinois, 60026, United States
Chicago Advocate Christ
Palos Park, Illinois, 60464, United States
Ascension Medical Group St. Vincent The Heart Center of Indiana
Indianapolis, Indiana, 46260, 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 St Louis
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke Cardiology Clinic
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oregon Health Services
Portland, Oregon, 97239, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, 17107, United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15232, United States
WellSpan York Hospital
York, Pennsylvania, 17403, 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
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
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Publications (4)
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.
PMID: 35583363BACKGROUNDAmat-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: 37083622BACKGROUNDAbdul-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.
PMID: 35499708BACKGROUNDChandran 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.
PMID: 37278243RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Katharina Kiss, MD
Products & Features GmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 18, 2023
Study Start
July 23, 2024
Primary Completion
November 1, 2025
Study Completion (Estimated)
September 1, 2029
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Available on request, Published as a supplement to the results publication.
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.