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New heart valve device aims to ease severe leak

NCT ID NCT06458907

Disease control Sponsor: P+F Products + Features USA Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This study tests a device called TricValve for people with severe tricuspid regurgitation, a condition where a heart valve leaks. The device is implanted in the veins to help blood flow better. About 780 participants will be randomly assigned to get the device plus standard medical therapy or just standard therapy. The goal is to see if the device improves symptoms and reduces hospitalizations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TricValve System (a device implanted in the veins to help blood flow)
What this could lead to
If successful, this could offer a new treatment option for people with severe tricuspid regurgitation who have limited alternatives, potentially improving their quality of life and reducing heart failure hospitalizations.
What could go wrong
This is a pivotal trial, but the device is still experimental. Risks include complications from the implant procedure, and it may not work for everyone. The study is not yet recruiting, so results are years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 780 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart failure heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Heart failure Heart valve diseases Tricuspid valve disease Tricuspid valve insufficiency Tricuspid valve regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension Medical Group St. Vincent The Heart Center of Indiana

    Indianapolis, Indiana, 46260, United States

  • Baylor Scott & White Medical

    Plano, Texas, 75093, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Endeavor Health

    Glenview, Illinois, 60026, United States

  • HCA Florida Largo Hospital

    Largo, Florida, 33770, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Intermountain Heart Institute - Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Kaiser Permanente

    San Jose, California, 94118, United States

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Washington Hospital Center (MWHC)

    Washington D.C., District of Columbia, 20010, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Northwell Hospital

    Manhasset, New York, 11030, United States

  • Oregon Health

    Portland, Oregon, 97239, United States

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Saint Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111, United States

  • Scripps Memorial Hospital La Jolla

    San Diego, California, 92037, United States

  • Sentara Healthcare

    Norfolk, Virginia, 23507, United States

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • UC Davis Health

    Sacramento, California, 95817, United States

  • UCSF

    San Francisco, California, 94143, United States

  • UVA School of Medicine

    Charlottesville, Virginia, 22903, United States

  • University of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103, United States

  • University of Texas (Memorial Hermann)

    Houston, Texas, 77030, United States

  • Washington University of St Louis

    St Louis, Missouri, 63110, United States

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