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Tricuspid RegurgitationTRICAV-INCT06137807

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

A study testing TricValve® Transcatheter Bicaval Valve System in people with Tricuspid Regurgitation and Tricuspid Valve Disease, run by P+F Products + Features USA Inc. at 36 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TricValve® Transcatheter Bicaval Valve System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
36 sitesUnited States
Study dates
23 Jul 2024to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.
  • Platelet count < 75,000/mm3
  • Child-Pugh Severity Class C (10-15 points).
  • 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.
  • Endocarditis or active/ongoing infection requiring antibiotics.
  • Unable to walk at least 60 meters in a 6minute walk test.
  • Known bleeding or clotting disorders or patient refuses blood transfusion.
  • Active gastrointestinal (GI) bleeding within 3 months of randomization.
  • Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
  • 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.
  • Any other condition that would preclude 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • 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

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • Duke Cardiology Clinic

    Durham, North Carolina, 27710

  • Endeavor Health, Glenbrook Hospital

    Glenview, Illinois, 60026

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • UPMC Pinnacle

    Harrisburg, Pennsylvania, 17107

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • 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

  • Saint Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111

  • Largo Medical Center

    Largo, Florida, 33770

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • MedStar Washington Hospital Center

    Multiple Locations, Washington, 20010

  • Intermountain Heart Institute - Intermountain Medical Center

    Murray, Utah, 84107

  • Sentara Healthcare

    Norfolk, Virginia, 23507

  • Chicago Advocate Christ

    Palos Park, Illinois, 60464

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health Services

    Portland, Oregon, 97239

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • Scripps Memorial Hospital La Jolla

    San Diego, California, 92037

  • UCSF

    San Francisco, California, 94143

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Washington University St Louis

    St Louis, Missouri, 63110

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Tucson Medical Center

    Tucson, Arizona, 85712

  • WellSpan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
TricValve® Transcatheter Bicaval Valve System
Keywords
Tricuspid Regurgitation, Heart Failure
Medical subject headings
Tricuspid Valve Insufficiency, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TricValve® Transcatheter Bicaval Valve SystemDevice

    Also called TricValve 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.

Study groups in NCT06137807
Study groupRoleWhat they receive
TricValve® Device (Device) GroupExperimentalsubjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.
Receives: Device: TricValve® Transcatheter Bicaval Valve System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Number of days until death

    Measured: 1 Month and 12 Months

  2. Stroke

    Number of days until death

    Measured: 1 Month

  3. Pulmonary Embolism

    Number of days until death

    Measured: 1 Month

  4. Valve Academic Research Consortium (VARC) type 2-4 bleeding complication

    Number of days until death

    Measured: 1 Month

  5. Major vascular, access-related, or cardiac structural complication

    Number of days until death

    Measured: 1 Month

  6. 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

    Measured: 7 Days

  7. Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy

    Number of days until new renal replacement therapy

    Measured: 1 Month

  8. Emergency surgery or intervention related to the device/procedure complications

    Number of days until emergency surgery or intervention

    Measured: 1 Month

  9. Right Ventricular Assist Device (RVAD) implantation or heart transplant

    Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant

    Measured: 12 Months

  10. Tricuspid valve surgery or percutaneous tricuspid intervention

    Number of days until tricuspid valve surgery or percutaneous tricuspid intervention

    Measured: 12 Months

  11. Heart Failure Events

    Number of heart failure episodes including hospitalization, or worsening heart failure

    Measured: 12 Months

  12. Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

    Change in KCC score (score ranges between 0 and 100)

    Measured: 12 Months

  13. New York Heart Association (NYHA class)

    Change in NYHA class (range from I to IV)

    Measured: 12 Months

  14. Six Minute Walking Test (6MWT)

    Change in walking distance

    Measured: 12 Months

Secondary outcomes (10)

  1. 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

    Measured: Intraprocedural

  2. 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

    Measured: 1 Month

  3. 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

    Measured: 1 Month

  4. Mortality

    Number of days until death

    Measured: 12 Months

  5. RVAD implantation or heart transplant

    Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant

    Measured: 12 Months

  6. Tricuspid valve surgery or percutaneous tricuspid intervention

    Number of days until tricuspid valve surgery or percutaneous tricuspid intervention

    Measured: 12 Months

  7. 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

    Measured: 12 Months

  8. Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

    Change in KCCQ score (score ranges between 0 and 100)

    Measured: 12 Months

  9. New York Heart Association (NYHA class)

    Change in NYHA class (range from I to IV)

    Measured: 12 Months

  10. Six Minute Walking Test (6MWT)

    Change in walking distance

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start23 Jul 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Prospective, multicenter clinical trial. Subjects will be selected by their local Heart Team to be at high risk and deemed eligible by an independent eligibility committee (IEC).
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06137807
Sponsor's protocol ID
CTP-TRIC-005
Acronym
TRICAV-I
Status last verified
Aug 2026
First submitted
31 Oct 2023
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 35583363

  • 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 37083622

  • 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.

    PubMed 35499708

  • 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.

    PubMed 37278243

Questions about this trial

What is this clinical trial studying?

A study testing TricValve® Transcatheter Bicaval Valve System in people with Tricuspid Regurgitation and Tricuspid Valve Disease, run by P+F Products + Features USA Inc. at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 1 Month and 12 Months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06137807, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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